The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Modification To Medamicus Flowguard Peelable Introducer.
Device ID | K040150 |
510k Number | K040150 |
Device Name: | MODIFICATION TO 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 | 2004-01-23 |
Decision Date | 2004-02-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884450025434 | K040150 | 000 |
10884450021368 | K040150 | 000 |