The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Concentric Retriever X5, Model 90035; Concentric Retriever X6, Model 90037.
| Device ID | K040700 |
| 510k Number | K040700 |
| Device Name: | CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037 |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-17 |
| Decision Date | 2004-06-21 |
| Summary: | summary |