Coeur Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K971712 | COEUR 130 ML ANGIOGRAPHIC SYRINGE | October 8, 1997 |
| K965214 | COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) | March 28, 1997 |
| K960965 | FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 | September 12, 1996 |
| K890292 | PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE | June 22, 1989 |
| K885138 | CAPILLARY TUBE, BLOOD COLLECTION | February 7, 1989 |
| K885202 | 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR | January 31, 1989 |
| K881646 | UROLOGICAL CATHETER | June 16, 1988 |
| K874579 | COEUR CONTROL SYRINGE | January 19, 1988 |
| K873597 | TUBING, POLYETHYLENE | November 12, 1987 |
| K823920 | COEURLOCK STERILE DISPOS. ANGIOGRAPHIC | February 18, 1983 |