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510(k) K172487

Coaxial Dilator Set (Micro-Introducer) by Galt Medical Corp. — Product Code DRE

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 16, 2017
Date Received
August 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Galt Medical Corp.

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  • K182660 — GaltTWS (May 30, 2019)
  • K173287 — Elite HV Radial (December 21, 2017)
  • K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (July 5, 2016)
  • 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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  • K223472 — TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guard (December 15, 2022)
  • K212784 — TightRail Guardian Motorized Dilator Sheath (August 24, 2022)
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