Home / 510(k) Clearances / K052381

510(k) K052381

GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER by Zerusa Limited — Product Code DTL

K052381 is an FDA 510(k) premarket notification submitted by Zerusa Limited for the device "GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER". The FDA issued a decision of Substantially Equivalent on November 21, 2005. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Zerusa Limited has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2005
Date Received
August 30, 2005
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 Zerusa Limited

  • K101113 — GUARDIAN II NC HEMOSTASIS VALVE (May 21, 2010)
  • K092711 — GUARDIAN II HEMOSTASIS VALVE (October 1, 2009)
  • K073620 — GUARDIAN HEMOSTASIS VALVE (February 27, 2008)

Other clearances for product code DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (December 2, 2015)
  • 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)

FDA data resources