The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Hd Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131.
| Device ID | K091703 |
| 510k Number | K091703 |
| Device Name: | HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 |
| Classification | Catheter, Embolectomy |
| 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 | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-10-14 |
| Summary: | summary |