510(k) K140775
K140775 is an FDA 510(k) premarket notification submitted by Spectranetics Corporation for the device "TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 2014. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Spectranetics Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2014
- Date Received
- March 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Peripheral, Atherectomy
- Device Class
- Class II
- Regulation Number
- 870.4875
- Review Panel
- CV
- Submission Type