Home / 510(k) Clearances / K820229

510(k) K820229

NORTON FLOW DIRECTED THERMODILUTION CATH by Norton Performance Plastics Corp. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1982
Date Received
January 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
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)

Other clearances for product code DYG

  • K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe (December 9, 2024)
  • K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F (June 27, 2024)
  • K233824 — Swan-Ganz catheter (June 6, 2024)
  • K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanc (September 21, 2023)
  • K222117 — Swang-Ganz IQ pulmonary artery catheter (December 9, 2022)
  • K193466 — Swan-Ganz Catheters (February 16, 2020)
  • K160084 — Swan Ganz Catheters (May 3, 2016)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS (June 18, 2008)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)