FDA product code · Cardiovascular
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
Product code DSY covers Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II device regulated under 21 CFR 870.3450. FDA has cleared 188 devices in this code, 2 of them in the last 12 months. Median review time across the 188 most recent decisions is 88 days. openFDA lists 86 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.3450
- Review panel
- Cardiovascular
- Clearances
- 188
What is happening in DSY right now?
DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter) has one finding. 2 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1492-2026, Z-0036-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1492-2026, Z-0036-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DSY?
FDA has cleared 188 devices under product code DSY since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular Graft | Maquet Cardiovascular, LLC | |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | |
| K241550 | Gelweave Vascular Prostheses | Vascutek, Ltd. | |
| K241070 | Gelsoft Plus Vascular Prostheses | Vascutek, Ltd. | |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. |
How long does FDA review take for DSY?
The median FDA review time for DSY is 88 days, measured across the 188 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DSY?
openFDA lists 86 recall records against product code DSY. A recall record covers one firm's corrective action and may span many device lots.
Z-1492-2026Open, ClassifiedVascutek, Ltd.
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging.
Z-0036-2026Open, ClassifiedW. L. Gore & Associates, Inc.
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Z-1952-2024Open, ClassifiedAtrium Medical Corporation
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1953-2024Open, ClassifiedAtrium Medical Corporation
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Z-1955-2024Open, ClassifiedAtrium Medical Corporation
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Showing the 5 most recently initiated of 86. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DSY?
MAUDE holds 485 adverse-event reports naming product code DSY, 95 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DSY unusual?
2 months sit above DSY's own expected range: 1 January 2025, 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 5 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 24 | 0–22 | Above expected (0–22) | |
| 5 | 0–25 | Within expected (0–25) | |
| 9 | 0–24 | Within expected (0–24) | |
| 9 | 0–25 | Within expected (0–25) | |
| 31 | 0–21 | Above expected (0–21) | |
| 10 | 0–34 | Within expected (0–34) | |
| 19 | 0–49 | Within expected (0–49) | |
| 4 | 0–36 | Within expected (0–36) | |
| 9 | 0–35 | Within expected (0–35) | |
| 19 | 0–33 | Within expected (0–33) | |
| 14 | 0–31 | Within expected (0–31) | |
| 7 | 0–35 | Within expected (0–35) | |
| 8 | 0–38 | Within expected (0–38) | |
| 6 | 0–29 | Within expected (0–29) | |
| 29 | 0–30 | Within expected (0–30) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DSY.
What are the predicate devices in DSY?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DSY?
Across the 188 most recent decisions, these applicants filed most often in DSY.
| Applicant | Recent clearances |
|---|---|
| W. L. Gore & Associates, Inc. | 23 |
| Vascutek, Ltd. | 22 |
| Atrium Medical Corp. | 16 |
| Meadox Medicals, Div. Boston Scientific Corp. | 15 |
| Intervascular, Inc. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in DSY file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| W. L. Gore & Associates, Inc. | 24 | 2 |
| Atrium Medical Corporation | 18 | 2 |
| Intervascular, Inc. | 17 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DSY
Get an email the morning anything changes in DSY — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.