The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Angiographic Drape Packs.
| Device ID | K840281 |
| 510k Number | K840281 |
| Device Name: | ANGIOGRAPHIC DRAPE PACKS |
| Classification | Injector And Syringe, Angiographic |
| Applicant | MEDRAD, INC. 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 | 1984-01-23 |
| Decision Date | 1984-04-17 |