The following data is part of a premarket notification filed by Genesis Medical Interventional, Inc. with the FDA for F.a.s.t. System Sed And Cxd.
| Device ID | K092623 |
| 510k Number | K092623 |
| Device Name: | F.A.S.T. SYSTEM SED AND CXD |
| Classification | Catheter, Embolectomy |
| Applicant | GENESIS MEDICAL INTERVENTIONAL, INC. 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden GENESIS MEDICAL INTERVENTIONAL, INC. 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2009-10-30 |
| Summary: | summary |