Home / 510(k) Clearances / K140028

510(k) K140028

GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER by Galt Medical Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2014
Date Received
January 6, 2014
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.

  • K192195 — Sterile Dilator (September 26, 2019)
  • K182660 — GaltTWS (May 30, 2019)
  • K173287 — Elite HV Radial (December 21, 2017)
  • K172487 — Coaxial Dilator Set (Micro-Introducer) (October 16, 2017)
  • K153533 — Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (July 5, 2016)
  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • 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)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)