The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Merci Retriever, Models 90065, 90066.
| Device ID | K033736 |
| 510k Number | K033736 |
| Device Name: | MERCI RETRIEVER, MODELS 90065, 90066 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Kevin F Macdonald |
| Correspondent | Kevin F Macdonald CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-08-11 |
| Summary: | summary |