The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Jetstream Navitus L System Jeystream Navitus System Jetstream G3 Sf System Jetstream Sf 1.6 System.
| Device ID | K122916 |
| 510k Number | K122916 |
| Device Name: | JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MEDRAD, INC. 10801 120TH AVENUE NE Kirkland, WA 98033 |
| Contact | Brit Baird |
| Correspondent | Brit Baird MEDRAD, 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 | 2012-09-21 |
| Decision Date | 2012-10-19 |
| Summary: | summary |