The following data is part of a premarket notification filed by Micro Vention, Inc. with the FDA for Headway 27 Microcatheter.
Device ID | K110813 |
510k Number | K110813 |
Device Name: | HEADWAY 27 MICROCATHETER |
Classification | Catheter, Percutaneous |
Applicant | MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Contact | Naomi Gong |
Correspondent | Naomi Gong MICRO VENTION, INC. 1311 VALENCIA AVENUE Tustin, CA 92780 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-24 |
Decision Date | 2011-08-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811425020449 | K110813 | 000 |
00810170016165 | K110813 | 000 |