The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Evacuplege Catheter.
| Device ID | K853128 |
| 510k Number | K853128 |
| Device Name: | SARNS EVACUPLEGE CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Marshall Smith |
| Correspondent | Marshall Smith 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-26 |
| Decision Date | 1985-10-17 |