The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Low Jetting Aortic Arch Cannula.
| Device ID | K934127 |
| 510k Number | K934127 |
| Device Name: | SARNS LOW JETTING AORTIC ARCH CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | James Balun |
| Correspondent | James Balun 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-25 |
| Decision Date | 1994-02-22 |