The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Angeflator(tm).
| Device ID | K902377 |
| 510k Number | K902377 |
| Device Name: | ANGEFLATOR(TM) |
| Classification | Injector And Syringe, Angiographic |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Brucker, Phd |
| Correspondent | Brucker, Phd ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-12-13 |