The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Merci Retriever.
Device ID | K081305 |
510k Number | K081305 |
Device Name: | MERCI RETRIEVER |
Classification | Catheter, Thrombus Retriever |
Applicant | CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View, CA 94041 |
Contact | Kirsten Valley |
Correspondent | Kirsten Valley CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View, CA 94041 |
Product Code | NRY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-08 |
Decision Date | 2008-06-05 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MERCI RETRIEVER 76368160 2744452 Live/Registered |
STRYKER CORPORATION 2002-02-06 |