The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Two-state Wire Reinforced Catheter.
| Device ID | K810415 |
| 510k Number | K810415 |
| Device Name: | SARNS TWO-STATE WIRE REINFORCED CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-18 |
| Decision Date | 1981-03-17 |