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510(k) K102645

WILLOW/ELM PTA BALLOON DILATATION CATHETER by Creagh Medical, Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
September 13, 2010
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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  • K171251 — 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (September 8, 2017)
  • K113468 — ELM PTA BALLON DILATATION CATHETER (December 20, 2011)

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