510(k) K103618
K103618 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 5, 2011. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Ev3, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2011
- Date Received
- December 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type