The following data is part of a premarket notification filed by Aros Surgical Instruments Corporation with the FDA for Vein Clamps, Artery Clamps.
| Device ID | K161315 |
| 510k Number | K161315 |
| Device Name: | Vein Clamps, Artery Clamps |
| Classification | Clamp, Vascular |
| Applicant | AROS Surgical Instruments Corporation 2111 Descanso Newport Beach, CA 92660 |
| Contact | Fred Phleps |
| Correspondent | Greg Holland Regulatory Specialist, Inc. 3722 Ave. Sausalito Irvine, CA 92606 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-11 |
| Decision Date | 2016-08-18 |
| Summary: | summary |