Medical device manufacturer
Scimed Life Systems, Inc.
Scimed Life Systems, Inc. holds 109 FDA 510(k) clearances across 17 product codes. Median elapsed review time is 84 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 109
- Product codes
- 17
- Median review
- 84 days
- Recall records
- 0
How does FDA spell Scimed Life Systems, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Scimed Life Systems, Inc. file in?
17 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | 30 | 88 days | |
| DQY | Catheter, Percutaneous | 17 | 82 days | |
| DQO | Catheter, Intravascular, Diagnostic | 16 | 80 days | |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 | 91 days | |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 | 69 days | |
| KRA | Catheter, Continuous Flush | 6 | 90 days | |
| DTP | Defoamer, Cardiopulmonary Bypass | 4 | 68 days | |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 3 | 46 days | |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 | 119 days | |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 114 days | |
| MAV | Syringe, Balloon Inflation | 2 | 48 days | |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 1 | 49 days | |
| DXT | Injector And Syringe, Angiographic | 1 | 93 days | |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 | 85 days | |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 15 days | |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 78 days | |
| MFY | Endothelial Cell Harvesting Kit | 1 | 223 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 Scimed Life Systems, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Scimed Life Systems, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | DQX | 365 | |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | DQO | 90 | |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | DQX | 90 | |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | DQO | 80 | |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | DQY | 65 | |
| K973945 | LUGE GUIDE WIRE | DQX | 88 | |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | DQY | 89 | |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID | DQX | 189 | |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | DQX | 65 | |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE | DQX | 78 |
Source: openFDA device/510k · retrieved
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