The following data is part of a premarket notification filed by Promedica Products, Inc. with the FDA for The Carpentier Trans-mitral Ventricular Vent(tm).
| Device ID | K883412 |
| 510k Number | K883412 |
| Device Name: | THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Contact | Lee Hand |
| Correspondent | Lee Hand PROMEDICA PRODUCTS, INC. 620 NEWPORT CENTER DR., SUITE 575 Newport Beach, CA 92660 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-02-08 |