Sulzer Carbomedics, Inc.: FDA clearances and approvals
Sulzer Carbomedics, Inc. has 8 FDA 510(k) clearances (first 1998, latest 2002), across 4 product codes in 1 review panel. Median 510(k) review time: 161 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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | 3 | 3 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 2 | 2 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| MOP | Rotator, Prosthetic Heart Valve | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Sulzer Carbomedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023185 | ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800 | KRH | 2002-12-17 | 84 |
| K013022 | SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS | DSY | 2002-06-13 | 279 |
| K021051 | ANNULOFLO SYSTEM, MITRAL MODEL AR700 | KRH | 2002-04-23 | 22 |
| K002007 | SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS | DSY | 2001-01-25 | 206 |
| K993288 | SULZER CARBOMEDICS CARDIOFIX PERICARDIUM | DXZ | 1999-12-29 | 89 |
| K992056 | ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800 | KRH | 1999-10-12 | 116 |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | MOP | 1998-08-04 | 235 |
| K972201 | PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE | DXZ | 1998-04-14 | 307 |
Recalls
openFDA lists no recalls under a recalling firm named Sulzer Carbomedics, 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.
Frequently asked questions
How many FDA 510(k) clearances does Sulzer Carbomedics, Inc. have?
Sulzer Carbomedics, Inc. has 8 FDA 510(k) clearances (first 1998, latest 2002), across 4 product codes in 1 review panel.
How long does FDA take to clear Sulzer Carbomedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Sulzer Carbomedics, Inc.'s cleared 510(k)s is 161 days.
What devices does Sulzer Carbomedics, Inc. make?
Its most frequent FDA product codes are KRH (Ring, Annuloplasty, 3); DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 2); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2).
Has Sulzer Carbomedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Sulzer Carbomedics, Inc. Related entities may recall under other names.
Next steps
- See all 8 Sulzer Carbomedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KRH, Sulzer Carbomedics, 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.