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510(k) K173287

Elite HV Radial by Galt Medical Corp. — Product Code DYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 21, 2017
Date Received
October 16, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • K140028 — GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER (August 21, 2014)
  • K123430 — MICROSLIDER TEARAWAY INTRODUCER SET (April 12, 2013)
  • K112398 — TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SI (April 12, 2012)
  • K071330 — GALTSTICK INTRODUCER SYSTEM (October 31, 2007)
  • K043525 — CATHETER INTRODUCER (February 9, 2005)

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