The following data is part of a premarket notification filed by Genesis Medical Interventional, Inc. with the FDA for Genesis Medical Interventional F.a.s.t. (facilitated Aspiration/suction Thrombectomy) Systems.
| Device ID | K040010 |
| 510k Number | K040010 |
| Device Name: | GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS |
| Classification | Catheter, Embolectomy |
| Applicant | GENESIS MEDICAL INTERVENTIONAL, INC. 652 BAIR ISLAND ROAD SUITE 103 Redwood City, CA 94063 |
| Contact | Anne Worden |
| Correspondent | Anne Worden GENESIS MEDICAL INTERVENTIONAL, INC. 652 BAIR ISLAND ROAD SUITE 103 Redwood City, CA 94063 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-05 |
| Decision Date | 2004-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B251TWA1 | K040010 | 000 |
| B251MTSA2 | K040010 | 000 |
| B251MCA1 | K040010 | 000 |