The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Retriever (modified, Line Extension), Models 90152, 90153.
| Device ID | K093610 |
| 510k Number | K093610 |
| Device Name: | MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 |
| Classification | Catheter, Thrombus Retriever |
| 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 | NRY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-20 |
| Decision Date | 2011-02-17 |
| Summary: | summary |