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510(k) K113468

ELM PTA BALLON DILATATION CATHETER by Creagh Medical, Ltd. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2011
Date Received
November 22, 2011
Clearance Type
Special
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)
  • K102645 — WILLOW/ELM PTA BALLOON DILATATION CATHETER (December 10, 2010)

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