The following data is part of a premarket notification filed by 3m Health Care with the FDA for Sarns Arterial Cannulae With Duraflo Treatment.
| Device ID | K964373 |
| 510k Number | K964373 |
| Device Name: | SARNS ARTERIAL CANNULAE WITH DURAFLO TREATMENT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Contact | Jason Smith |
| Correspondent | Jason Smith 3M HEALTH CARE 6200 JACKSON RD. Ann Arbor, MI 48103 -9300 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-06-18 |
| Summary: | summary |