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510(k) K160256

Polux , Minerva and Atropos PTA Balloon Dilatation Catheter by Brosmed Medical Co., Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2016
Date Received
February 1, 2016
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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  • K160941 — Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter (December 13, 2016)
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