The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Angestat(r) Pericardial Drainage Sheath Set.
| Device ID | K925533 |
| 510k Number | K925533 |
| Device Name: | ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET |
| Classification | Catheter, Irrigation |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Bruce D Henke |
| Correspondent | Bruce D Henke ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-01-12 |