The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream G3 Se System, Jetstream G3 Sf System Model Pv31230 (jetstream G3 Se Catheter And Control Pod); Pvcn100 (pv Con.
| Device ID | K101334 |
| 510k Number | K101334 |
| Device Name: | JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | PATHWAY MEDICAL TECHNOLOGIES, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Contact | Cyndy Adams |
| Correspondent | Cyndy Adams 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 | 2010-05-12 |
| Decision Date | 2010-06-11 |
| Summary: | summary |