510(k) K093301
K093301 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 6, 2009. 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
- November 6, 2009
- Date Received
- October 21, 2009
- 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