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510(k) K181128

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) by Contego Medical, LLC — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2018
Date Received
April 30, 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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  • K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Prote (December 6, 2018)

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