The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Cpc, Couble Lumen Cardioplegia-air Aspi.
| Device ID | K832124 |
| 510k Number | K832124 |
| Device Name: | CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MED-WEST, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-30 |
| Decision Date | 1983-08-12 |