The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Valved Peelable Introducer.
Device ID | K021004 |
510k Number | K021004 |
Device Name: | VALVED 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-28 |
Decision Date | 2002-06-06 |
Summary: | summary |