The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Atraumax(tm) Surgical Clamps.
| Device ID | K891296 |
| 510k Number | K891296 |
| Device Name: | ATRAUMAX(TM) SURGICAL CLAMPS |
| Classification | Clamp, Vascular |
| Applicant | APPLIED VASCULAR DEVICES, INC. 2740 S. HARBOR, SUITE K Santa Ana, CA 92704 |
| Contact | Said S Hilal |
| Correspondent | Said S Hilal APPLIED VASCULAR DEVICES, INC. 2740 S. HARBOR, SUITE K Santa Ana, CA 92704 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-13 |
| Decision Date | 1989-06-07 |