The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Medamicus Flowguard Peelable Introducer.
| Device ID | K030905 |
| 510k Number | K030905 |
| Device Name: | MEDAMICUS FLOWGUARD PEELABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Karyl Haskell |
| Correspondent | Karyl Haskell MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-04-09 |
| Summary: | summary |