Coeur, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Coeur, Inc.” (first 2005, latest 2017), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 171 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 163 |
| 2013 | 1 | 444 |
| 2014 | 2 | 154 |
| 2015 | 2 | 196 |
| 2016 | 1 | 132 |
| 2017 | 1 | 186 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Coeur, Inc. took a median 186 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 10 | 10 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (3)
Most recent Coeur, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170431 | CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip | DXT | 2017-08-18 | 186 |
| K161471 | MR Syringe Dual Pack for Solaris Injectors | DXT | 2016-10-06 | 132 |
| K150902 | 330psi Extension Y-Line with Dual Check Valve | DXT | 2015-10-22 | 202 |
| K142745 | 125mL CT Syringe | DXT | 2015-04-01 | 189 |
| K140469 | MR SYRINGE DUAL PACK | DXT | 2014-07-28 | 153 |
| K133600 | COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR | DXT | 2014-04-30 | 156 |
| K120892 | DISPOSABLE 330PSI EXTENSION LINES | DXT | 2013-06-10 | 444 |
| K113498 | DISPOSABLE TORQUE DEVICE | DQX | 2012-07-20 | 238 |
| K113132 | DISPOSABLE HEMOSTATIC Y-CONNECTORS | DTL | 2012-01-20 | 88 |
| K090487 | DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 | DXT | 2009-10-19 | 236 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coeur, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Coeur Laboratories, Inc. (10 510(k)s)
- Coeur Medical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coeur, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Coeur, Inc.” (first 2005, latest 2017), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coeur, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coeur, Inc. is 171 days.
Which FDA product codes appear under Coeur, Inc.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 10); DQO (Catheter, Intravascular, Diagnostic, 1); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 14 Coeur, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Coeur, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.