The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Flowgate Balloon Guide Catheter.
| Device ID | K131492 |
| 510k Number | K131492 |
| Device Name: | MODIFIED FLOWGATE BALLOON GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL, INC. 301 E Evelyn Ave Mountain View, CA 94041 |
| Contact | Rhoda Santos |
| Correspondent | Rhoda Santos 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 | 2013-05-23 |
| Decision Date | 2013-10-03 |
| Summary: | summary |