The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Balloon Guide Catheter.
| Device ID | K112404 |
| 510k Number | K112404 |
| 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 | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2012-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815742000771 | K112404 | 000 |
| 00815742000764 | K112404 | 000 |
| 00815742000740 | K112404 | 000 |
| 00815742000733 | K112404 | 000 |
| 00815742000726 | K112404 | 000 |