The following data is part of a premarket notification filed by Invasatec with the FDA for Acist Angiographic Injector.
| Device ID | K963982 |
| 510k Number | K963982 |
| Device Name: | ACIST ANGIOGRAPHIC INJECTOR |
| Classification | Injector And Syringe, Angiographic |
| Applicant | INVASATEC 10180 VIKING LN. Eden Prairie, MN 55344 |
| Contact | Doug Duchon |
| Correspondent | Doug Duchon INVASATEC 10180 VIKING LN. Eden Prairie, MN 55344 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-12-05 |
| Summary: | summary |