The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream G2 System, Models Pv20300 (jetstream G2 Catheter And Control Pod); Pvcn100 (pv Console).
| Device ID | K090325 |
| 510k Number | K090325 |
| Device Name: | JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Contact | Brit Baird |
| Correspondent | Brit Baird PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-09 |
| Decision Date | 2009-03-11 |
| Summary: | summary |