510(k) K123632
K123632 is an FDA 510(k) premarket notification submitted by Spectranetics Corp. for the device "2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035". The FDA issued a decision of Substantially Equivalent on January 25, 2013. The device falls under product code MCW (Catheter, Peripheral, Atherectomy), a Class II device regulated under 21 CFR 870.4875. Spectranetics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2013
- Date Received
- November 23, 2012
- 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