The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modification To Merci Retriever, Models X5 And X6.
| Device ID | K063774 |
| 510k Number | K063774 |
| Device Name: | MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6 |
| Classification | Catheter, Thrombus Retriever |
| Applicant | CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Contact | Kirsten Valley |
| Correspondent | Kirsten Valley CONCENTRIC MEDICAL, INC. 1380 SHOREBIRD WAY Mountain View, CA 94043 |
| Product Code | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-21 |
| Decision Date | 2007-01-24 |
| Summary: | summary |