The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Heart/lung Perfusion And Cardioplegia Pack.
| Device ID | K881330 |
| 510k Number | K881330 |
| Device Name: | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Lynette Makowski |
| Correspondent | Lynette Makowski COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-29 |
| Decision Date | 1988-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622128360 | K881330 | 000 |