The following data is part of a premarket notification filed by Vertex Medical Corp. with the FDA for Ultra-asept Angiographic Syringe/spare.
| Device ID | K823256 |
| 510k Number | K823256 |
| Device Name: | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | VERTEX MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-01 |
| Decision Date | 1982-12-30 |