The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Hd Guide Catheter.
| Device ID | K080583 |
| 510k Number | K080583 |
| Device Name: | MODIFIED HD GUIDE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View, CA 94041 |
| Contact | Laraine Pangelina |
| Correspondent | Laraine Pangelina CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View, CA 94041 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-03 |
| Decision Date | 2008-07-18 |
| Summary: | summary |