The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Trevo Provue Retriever.
| Device ID | K132641 |
| 510k Number | K132641 |
| Device Name: | MODIFIED TREVO PROVUE RETRIEVER |
| Classification | Catheter, Thrombus Retriever |
| Applicant | CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View, CA 94041 |
| Contact | Sarah Meyer |
| Correspondent | Sarah Meyer 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 | 2013-08-26 |
| Decision Date | 2014-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742001839 | K132641 | 000 |
| 00815742001822 | K132641 | 000 |