The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter.
| Device ID | K123544 |
| 510k Number | K123544 |
| Device Name: | RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | EV3 INC 3033 CAMPUS DRIVE Plymouth, MN 55441 -2651 |
| Contact | Laura J Lind |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2013-02-12 |
| Summary: | summary |