The following data is part of a premarket notification filed by Angeion Corp. with the FDA for Catheter Introducer.
| Device ID | K871153 |
| 510k Number | K871153 |
| Device Name: | CATHETER INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Contact | Lawrence M Kane |
| Correspondent | Lawrence M Kane ANGEION CORP. 13000 HIGHWAY 55 Plymouth, MN 55441 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-06-24 |