The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream Pathway Pc Atherectomy System, Model Ov10300.
| Device ID | K083489 |
| 510k Number | K083489 |
| Device Name: | JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300 |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Contact | Brian Cleary |
| Correspondent | Brian Cleary 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 | 2008-11-25 |
| Decision Date | 2009-01-23 |
| Summary: | summary |