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510(k) K063114

DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES by Coeur, Inc. — Product Code FPK

K063114 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES". The FDA issued a decision of Substantially Equivalent on February 9, 2007. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Coeur, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2007
Date Received
October 11, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Fluid Delivery
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
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)
  • K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORS (January 20, 2012)
  • K090487 — DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL S (October 19, 2009)

Other clearances for product code FPK

  • K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING (August 2, 2013)
  • K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, (December 11, 2006)
  • K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801 (November 29, 2005)
  • K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) (July 16, 2004)
  • K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET (July 11, 2003)
  • K022431 — MEDRAD TRANSFER SET (September 5, 2002)
  • K965208 — POLYFIN EXTENSION SET, MODELS 126 AND 128 (February 26, 1997)
  • K953864 — SILCLEAR TUBING (MODIFICATION) (November 6, 1995)
  • K950508 — SYSMEX SF-3000 (November 3, 1995)
  • K952243 — EXTENSION SET/I.V. SET (July 26, 1995)

FDA data resources