The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Balloon Guide Catheter Model 90253, 90254.
| Device ID | K122581 |
| 510k Number | K122581 |
| Device Name: | MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2012-11-21 |
| Summary: | summary |