The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Merci Retriever, Models 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113.
| Device ID | K090085 |
| 510k Number | K090085 |
| Device Name: | MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113 |
| Classification | Catheter, Thrombus Retriever |
| 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 | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-13 |
| Decision Date | 2009-02-12 |
| Summary: | summary |