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510(k) K113132

DISPOSABLE HEMOSTATIC Y-CONNECTORS by Coeur, Inc. — Product Code DTL

K113132 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE HEMOSTATIC Y-CONNECTORS". The FDA issued a decision of Substantially Equivalent on January 20, 2012. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Coeur, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
October 24, 2011
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 Coeur, Inc.

  • K170431 — CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tu (August 18, 2017)
  • K161471 — MR Syringe Dual Pack for Solaris Injectors (October 6, 2016)
  • K150902 — 330psi Extension Y-Line with Dual Check Valve (October 22, 2015)
  • K142745 — 125mL CT Syringe (April 1, 2015)
  • K140469 — MR SYRINGE DUAL PACK (July 28, 2014)
  • K133600 — COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR (April 30, 2014)
  • K120892 — DISPOSABLE 330PSI EXTENSION LINES (June 10, 2013)
  • K113498 — DISPOSABLE TORQUE DEVICE (July 20, 2012)
  • K090487 — DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL S (October 19, 2009)
  • K070798 — ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS (October 4, 2007)

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