The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Jetstream Xc 2.4/3.4 System; Jetstream Xc 2.1/3.0 System; Jetstream Sc 1.85 System; Jetstream Sc 1.6 System.
| Device ID | K130637 |
| 510k Number | K130637 |
| Device Name: | JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 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 | 2013-03-11 |
| Decision Date | 2013-04-10 |
| Summary: | summary |