The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream G3 L System, Pv Console, Models Pv31400, Pv31300, Pvcn100.
| Device ID | K100462 |
| 510k Number | K100462 |
| Device Name: | JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-18 |
| Decision Date | 2010-05-19 |
| Summary: | summary |