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510(k) K242419

018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter by Creagh Medical Ltd. Dba Surmodics, Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2024
Date Received
August 15, 2024
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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