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510(k) K031398

IS-1 HEMOSTASIS VALVE, MODEL 6799 by Guidant Corp. — Product Code DTL

K031398 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "IS-1 HEMOSTASIS VALVE, MODEL 6799". The FDA issued a decision of Substantially Equivalent on May 20, 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 Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2003
Date Received
May 5, 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 Corp.

  • K061865 — FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (July 27, 2006)
  • K061453 — HI-TORQUE WHISPER VIEW GUIDE WIRE (June 22, 2006)
  • K042908 — RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (November 12, 2004)
  • K042218 — ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 31, 2004)
  • K033834 — OMNILINK .018 BILIARY STENT SYSTEM (January 2, 2004)
  • K033393 — ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (November 10, 2003)
  • K031678 — HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (August 26, 2003)
  • K031459 — RAPIDO CUT-AWAY CUTTER (July 23, 2003)
  • K030512 — GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (May 14, 2003)
  • K030019 — MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (January 24, 2003)

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