The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 8.0 Soft Arc Cannula.
| Device ID | K834134 |
| 510k Number | K834134 |
| Device Name: | SARNS 8.0 SOFT ARC CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 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 | 1983-11-30 |
| Decision Date | 1984-04-17 |