The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Jetstream System.
| Device ID | K133023 |
| 510k Number | K133023 |
| Device Name: | JETSTREAM SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MEDRAD, INC. 9055 EVERGREEN BLVD. NW Minneapolis, MN 55433 |
| Contact | Arma Racic |
| Correspondent | George Lucas MEDRAD, INC. 8880 EVERGREEN BLVD. NW Minneapolis, MN 55433 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-26 |
| Decision Date | 2014-08-27 |
| Summary: | summary |