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510(k) K031688

RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE by Guidant Corporation — Product Code DTL

K031688 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE". The FDA issued a decision of Substantially Equivalent on July 2, 2003. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Guidant Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2003
Date Received
June 2, 2003
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 Guidant Corporation

  • K060449 — HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (May 30, 2006)
  • K053459 — OMNILINK .035 BILIARY STENT SYSTEM (April 12, 2006)
  • K053454 — RX HERCULINK ELITE BILIARY STENT SYSTEM (March 6, 2006)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (September 21, 2005)
  • K052166 — MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 18, 2005)
  • K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 16, 2005)
  • K041981 — GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSO (August 20, 2004)
  • K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)

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