Medical device manufacturer
Vascular Solutions, Inc.
Vascular Solutions, Inc. holds 115 FDA 510(k) clearances across 17 product codes. Median elapsed review time is 79 days. openFDA lists 29 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 115
- Product codes
- 17
- Median review
- 79 days
- Recall records
- 29
How does FDA spell Vascular Solutions, Inc.?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| VASCULAR SOLUTIONS LLC | device/registrationlisting | normalised |
| Vascular Solutions | device/510k | normalised |
| Vascular Solutions, Inc | device/recall | normalised |
| Vascular Solutions, Inc. | device/510k | normalised |
| Vascular Solutions, Inc. | device/recall | normalised |
| Vascular Solutions, Inc. | device/enforcement | normalised |
| Vascular Solutions, LLC | device/510k | normalised |
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Vascular Solutions, Inc. file in?
17 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | 27 | 113 days | |
| QSX | Hemostatic Wound Dressing With Thrombin Or Other Biologics | 18 | 41 days | |
| GEX | Powered Laser Surgical Instrument | 13 | 58 days | |
| QEZ | Aspiration Thrombectomy Catheter | 13 | 79 days | |
| DQO | Catheter, Intravascular, Diagnostic | 12 | 80 days | |
| DQX | Wire, Guide, Catheter | 11 | 59 days | |
| KRD | Device, Vascular, For Promoting Embolization | 5 | 118 days | |
| DXC | Clamp, Vascular | 3 | 88 days | |
| DYB | Introducer, Catheter | 3 | 223 days | |
| FMF | Syringe, Piston | 2 | 29 days | |
| MAV | Syringe, Balloon Inflation | 2 | 69 days | |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 90 days | |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 76 days | |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 28 days | |
| KHJ | Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | 1 | 341 days | |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 192 days | |
| MMX | Device, Percutaneous Retrieval | 1 | 105 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Vascular Solutions, Inc. had a recall?
openFDA lists 29 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-0110-2021Class ITerminatedDQO
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-0111-2021Class ITerminatedDQO
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-0112-2021Class ITerminatedDQO
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-0113-2021Class ITerminatedDQO
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Z-1747-2020Class ITerminatedDQO
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
Showing the 5 most recently initiated of 29.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Vascular Solutions, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | 192 | |
| K230637 | Wattson temporary pacing guidewire (2250) | DQX | 59 | |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | 164 | |
| K221470 | Langston dual lumen catheter | DQO | 28 | |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | DQY | 209 | |
| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | DQX | 212 | |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | 58 | |
| K193119 | Twin-Pass Dual Access Catheter | DQY | 230 | |
| K200720 | D-Stat Radial Topical Hemostat | QSX | 99 | |
| K192454 | Wattson Temporary Pacing Guidewire | DQX | 128 |
Source: openFDA device/510k · retrieved
Where is Vascular Solutions, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Vascular Solutions, Inc. files next
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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.