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510(k) K250385

Turbo-Elite Laser Atherectomy Catheter by Spectranetics — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2025
Date Received
February 11, 2025
Clearance Type
Special
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

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