The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Litwak-koffsky Obturated Cannu.
| Device ID | K821316 |
| 510k Number | K821316 |
| Device Name: | KONTRON LITWAK-KOFFSKY OBTURATED CANNU |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | KONTRON INSTRUMENTS, 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 | 1982-05-04 |
| Decision Date | 1982-08-06 |