The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Safety Loop.
| Device ID | K863593 |
| 510k Number | K863593 |
| Device Name: | SARNS SAFETY LOOP |
| Classification | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Contact | Joseph W O'donnell |
| Correspondent | Joseph W O'donnell 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DWD |
| CFR Regulation Number | 870.4430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-15 |
| Decision Date | 1986-11-18 |