The following data is part of a premarket notification filed by Invasatec with the FDA for Angiographic Contrast Management System, Model Part A And Part B.
| Device ID | K984231 |
| 510k Number | K984231 |
| Device Name: | ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B |
| Classification | Injector And Syringe, Angiographic |
| Applicant | INVASATEC 7450 FLYING CLOUD DR. SUITE 150 Eden Prairie, MN 55344 |
| Contact | Kate Anderson |
| Correspondent | Kate Anderson INVASATEC 7450 FLYING CLOUD DR. SUITE 150 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 | 1998-11-25 |
| Decision Date | 2000-05-31 |
| Summary: | summary |