Scimed Life Systems, Inc.: FDA clearances and approvals
Scimed Life Systems, Inc. has 109 FDA 510(k) clearances (first 1977, latest 1998), plus 2 PMA decisions, across 17 product codes in 2 review panels. Median 510(k) review time: 84 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 30 | 30 |
| DQY | Catheter, Percutaneous | 17 | 17 |
| DQO | Catheter, Intravascular, Diagnostic | 16 | 16 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 13 | 13 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 6 | 6 |
| KRA | Catheter, Continuous Flush | 6 | 6 |
| DTP | Defoamer, Cardiopulmonary Bypass | 4 | 4 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 3 | 3 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 3 |
Plus 7 more product codes.
Review panels
- Cardiovascular (110)
- General Hospital (1)
Most recent Scimed Life Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974241 | SCIMED INFORMER PRESSURE WIRE SYSTEM | DQX | 1998-11-12 | 365 |
| K981788 | SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER | DQO | 1998-08-18 | 90 |
| K980360 | SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES | DQX | 1998-04-29 | 90 |
| K974559 | SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS | DQO | 1998-02-23 | 80 |
| K974684 | SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER | DQY | 1998-02-19 | 65 |
| K973945 | LUGE GUIDE WIRE | DQX | 1998-01-12 | 88 |
| K970823 | SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER | DQY | 1997-06-03 | 89 |
| K964551 | CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID | DQX | 1997-05-21 | 189 |
| K970244 | SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES | DQX | 1997-03-28 | 65 |
| K965023 | CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE | DQX | 1997-03-04 | 78 |
99 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P940009 | PMA | PERCUTANEUS TRANSLUMINAL CORONARY ANGIOPLASTY CATH | 1994-09-29 |
| P860019 | PMA | SCIMED PTCA DILATATION CATHETER | 1986-11-28 |
Recalls
openFDA lists no recalls under a recalling firm named Scimed Life Systems, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Scimed Life Systems, Inc.'s product codes (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Frequently asked questions
How many FDA 510(k) clearances does Scimed Life Systems, Inc. have?
Scimed Life Systems, Inc. has 109 FDA 510(k) clearances (first 1977, latest 1998), plus 2 PMA decisions, across 17 product codes in 2 review panels.
How long does FDA take to clear Scimed Life Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Scimed Life Systems, Inc.'s cleared 510(k)s is 84 days.
What devices does Scimed Life Systems, Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 30); DQY (Catheter, Percutaneous, 17); DQO (Catheter, Intravascular, Diagnostic, 16).
Has Scimed Life Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Scimed Life Systems, Inc. Related entities may recall under other names.
Next steps
- See all 109 Scimed Life Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Scimed Life Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.