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510(k) K060759

Y-CLICK CONNECTOR by Elcam Medical Acal — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2006
Date Received
March 21, 2006
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 Elcam Medical Acal

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  • K190489 — Elcam Stopcocks and Manifolds (April 23, 2019)
  • K141254 — ELCAM STOPCOCKS AND MANIFOLDS (July 30, 2014)
  • K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MA (May 23, 2013)
  • K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) (July 16, 2012)
  • K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) (June 8, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K111016 — SAFEPORT MANIFOLD (TM) (OR STOPCOCK) (June 9, 2011)
  • K100425 — HASKAL TORQUE DEVICE (June 17, 2010)

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)