Coeur Laboratories, Inc.
NC, US
Coeur Laboratories, Inc. appears in FDA device records in NC. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Coeur Laboratories, Inc. between 1983 and 1997. The busiest year on record is 1989, with 3. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 3 |
| 1996 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | DXT | Substantially Equivalent | |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | DTX | Substantially Equivalent | |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | DXT | Substantially Equivalent | |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | DXT | Substantially Equivalent | |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | GIO | Substantially Equivalent | |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | KOD | Substantially Equivalent | |
| K881646 | UROLOGICAL CATHETER | KOD | Substantially Equivalent | |
| K874579 | COEUR CONTROL SYRINGE | FMF | Substantially Equivalent | |
| K873597 | TUBING, POLYETHYLENE | DXT | Substantially Equivalent | |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | DXT | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain