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510(k) K820864

NORTON MANIFOLD by Norton Performance Plastics Corp. — Product Code DTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1982
Date Received
March 29, 1982
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 Norton Performance Plastics Corp.

  • K853791 — NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 (December 9, 1985)
  • K852914 — ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION (September 25, 1985)
  • K851299 — CORRECT FLO (May 7, 1985)
  • K842858 — FLUID ADMINISTRATION LINE W/SPIKE 14-923 (September 11, 1984)
  • K841828 — CENTRAL VENOUS CATHETER W/BIG-GARD (July 13, 1984)
  • K840240 — MICROFUSE INTRAVENOUS CATHETER SET (April 17, 1984)
  • K831587 — TEMP. REPAIR KIT-DUAL LUMEN CATHETER (October 19, 1983)
  • K831698 — DISPOSABLE PRESSURE TRANSDUCER#14004195 (August 11, 1983)
  • K830788 — CENTRAL VEIN CATHERIZATION KIT-14-690- (April 30, 1983)
  • K830813 — FRENCH PERCUTANEOUS SHEATH INTRODUCER (April 28, 1983)

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  • 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)