The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Trevo Retriever.
| Device ID | K122478 |
| 510k Number | K122478 |
| Device Name: | MODIFIED TREVO RETRIEVER |
| Classification | Catheter, Thrombus Retriever |
| Applicant | CONCENTRIC MEDICAL, INC. 301 E Evelyn Ave Mountain View, CA 94041 |
| Contact | Christina Rowe |
| Correspondent | Christina Rowe 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 | 2012-08-14 |
| Decision Date | 2012-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742001846 | K122478 | 000 |