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510(k) K112797

POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER by Cordis Corp. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2012
Date Received
September 26, 2011
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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