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510(k) K152528

Attachable Cath Lab Hemostasis Valve by Galt Medical Corp. — Product Code DTL

K152528 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "Attachable Cath Lab Hemostasis Valve". The FDA issued a decision of Substantially Equivalent on December 2, 2015. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Galt Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2015
Date Received
September 3, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
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)
  • 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)

Other clearances for product code DTL

  • K143429 — Passage Hemostasis Valve (December 22, 2014)
  • K140475 — ROTATING ADAPTERS (April 16, 2014)
  • K131124 — COLIGN (August 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE L (December 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (October 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (September 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (April 3, 2012)
  • K113148 — E-PASS (February 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (January 25, 2012)
  • K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORS (January 20, 2012)

FDA data resources