The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Baxter Percutaneous Mechanical Thrombectomy (pmt) Device, Models Pmt0606fd And Pmt1206fd.
| Device ID | K993816 |
| 510k Number | K993816 |
| Device Name: | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Diane Peterson |
| Correspondent | Diane Peterson BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-10 |
| Decision Date | 2000-05-04 |
| Summary: | summary |