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510(k) K143041

Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter by Natec Medical , Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2015
Date Received
October 22, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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