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510(k) K181529

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection by Contego Medical, LLC — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2018
Date Received
June 11, 2018
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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