The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Injector Handle With Syringe.
| Device ID | K880987 |
| 510k Number | K880987 |
| Device Name: | INJECTOR HANDLE WITH SYRINGE |
| Classification | Injector And Syringe, Angiographic |
| 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 | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-08 |
| Decision Date | 1988-05-13 |