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510(k) K190037

Cronus HP PTA Balloon Catheter by Nipro Medical Corporation — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2019
Date Received
January 8, 2019
Clearance Type
Traditional
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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