The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Balloon Guide Catheter.
| Device ID | K102657 |
| 510k Number | K102657 |
| Device Name: | CONCENTRIC BALLOON GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-11-17 |
| Summary: | summary |