The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Angiojet Ultra Power Pulse Kit.
| Device ID | K130381 |
| 510k Number | K130381 |
| Device Name: | ANGIOJET ULTRA POWER PULSE KIT |
| Classification | Catheter, Continuous Flush |
| Applicant | MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Contact | Amra Racic |
| Correspondent | Amra Racic MEDRAD, INC. 9055 EVERGREEN BLVD NW Minneapolis, MN 55433 -8003 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-14 |
| Decision Date | 2013-07-29 |
| Summary: | summary |