The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Turbohawk Peropheral Plaque Excision System.
| Device ID | K103618 |
| 510k Number | K103618 |
| Device Name: | TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | EV3 INC 3033 Campus Drive Plymouth, MN 55441 |
| Contact | Brenda Johnson |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-10 |
| Decision Date | 2011-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684065853 | K103618 | 000 |
| 00821684065839 | K103618 | 000 |
| 00821684065815 | K103618 | 000 |
| 00821684047941 | K103618 | 000 |
| 00821684047934 | K103618 | 000 |
| 00821684047927 | K103618 | 000 |
| 00643169968226 | K103618 | 000 |
| 00643169968202 | K103618 | 000 |