The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Vip Plus Percutaneous Introducer.
| Device ID | K944107 |
| 510k Number | K944107 |
| Device Name: | VIP PLUS PERCUTANEOUS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | David A Liebl |
| Correspondent | David A Liebl 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 | 1994-08-23 |
| Decision Date | 1994-09-14 |