The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Trevo Retriever.
Device ID | K120961 |
510k Number | K120961 |
Device Name: | TREVO 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-03-30 |
Decision Date | 2012-08-03 |
Summary: | summary |