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510(k) K092711

GUARDIAN II HEMOSTASIS VALVE by Zerusa Limited — Product Code DTL

K092711 is an FDA 510(k) premarket notification submitted by Zerusa Limited for the device "GUARDIAN II HEMOSTASIS VALVE". The FDA issued a decision of Substantially Equivalent on October 1, 2009. 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
October 1, 2009
Date Received
September 3, 2009
Clearance Type
Special
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)
  • K073620 — GUARDIAN HEMOSTASIS VALVE (February 27, 2008)
  • K052381 — GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER (November 21, 2005)

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