The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Percutaneous Introducer.
| Device ID | K893658 |
| 510k Number | K893658 |
| Device Name: | PERCUTANEOUS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis Madison |
| Correspondent | Dennis Madison MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-03 |