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510(k) K171251

014 Hydrophilic Coated PTA Balloon Dilatation Catheter by Creagh Medical — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2017
Date Received
April 28, 2017
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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  • K180007 — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (April 19, 2018)
  • K113468 — ELM PTA BALLON DILATATION CATHETER (December 20, 2011)
  • K102645 — WILLOW/ELM PTA BALLOON DILATATION CATHETER (December 10, 2010)

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