The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream Pathway Pv Atherectomy System, Model Pv10300, Pvcn100.
| Device ID | K082664 |
| 510k Number | K082664 |
| Device Name: | JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Contact | Ken Perino |
| Correspondent | Ken Perino 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 | 2008-09-12 |
| Decision Date | 2008-10-06 |
| Summary: | summary |