The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Angeion Igital Angeflator.
| Device ID | K921757 |
| 510k Number | K921757 |
| Device Name: | ANGEION IGITAL ANGEFLATOR |
| Classification | Syringe, Balloon Inflation |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Steven W Huntley |
| Correspondent | Steven W Huntley ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-13 |
| Decision Date | 1993-03-18 |