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510(k) K955554

HEMO-VALVE by North American Instrument Corp. — Product Code DTL

K955554 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "HEMO-VALVE". The FDA issued a decision of Substantially Equivalent on March 4, 1996. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1996
Date Received
December 5, 1995
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 North American Instrument Corp.

  • K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) (March 29, 1996)
  • K960310 — EPIC INTRODUCER SHEATH (February 7, 1996)
  • K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS (March 3, 1993)
  • K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET (June 10, 1992)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)
  • K903606 — GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER (September 27, 1990)

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