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510(k) K142261

Ultraverse 035 PTA Balloon Dilatation Catheter by Bard Peripheral Vascular, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2014
Date Received
August 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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