The following data is part of a premarket notification filed by Surmodics, Inc. with the FDA for Microcatheter.
Device ID | K173560 |
510k Number | K173560 |
Device Name: | Microcatheter |
Classification | Catheter, Percutaneous |
Applicant | Surmodics, Inc. 9924 W 74th St Eden Prairie, MN 55344 |
Contact | Sherri Mellingen |
Correspondent | Sherri Mellingen Surmodics, Inc. 9924 W 74th St Eden Prairie, MN 55344 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-17 |
Decision Date | 2018-01-12 |
Summary: | summary |