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510(k) K192318

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters by Bard Peripheral Vascular, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2019
Date Received
August 26, 2019
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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Other clearances for product code LIT

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