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510(k) K820677

TOUCH FLUSH CONTINUOUS FAST/FLUSH by Norton Performance Plastics Corp. — Product Code DRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1982
Date Received
March 11, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Blood-Pressure, Extravascular
Device Class
Class II
Regulation Number
870.2850
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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  • K161408 — Compass Cast and MAP (November 22, 2016)
  • K152472 — Disposable Pressure Transducer (October 31, 2016)
  • K152980 — Flo Trac sensor, Volume View sensor (January 19, 2016)
  • K151040 — Art-line Single channel blood pressure system, Art-line Double channel blood pre (September 4, 2015)
  • K133624 — COMPASS CT, COMPASS CT PORT (April 18, 2014)
  • K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER (May 8, 2013)