The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Concentric Microcatheter.
| Device ID | K131437 |
| 510k Number | K131437 |
| Device Name: | MODIFIED CONCENTRIC MICROCATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| Subsequent Product Code | DQY |
| Subsequent Product Code | KRA |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742002317 | K131437 | 000 |