The following data is part of a premarket notification filed by Pathway Medical Technologies, Inc. with the FDA for Jetstream G3 (r) Sf 1.6 System.
| Device ID | K111229 |
| 510k Number | K111229 |
| Device Name: | JETSTREAM G3 (R) SF 1.6 SYSTEM |
| 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 | 2011-05-02 |
| Decision Date | 2011-06-01 |
| Summary: | summary |