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510(k) K153533

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer by Galt Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2016
Date Received
December 9, 2015
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

Other clearances by Galt Medical Corp.

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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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