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510(k) K771043

SWAN GANZ by Clincal Instruments Corp. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
June 9, 1977
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 Clincal Instruments Corp.

  • K902327 — EMBOLECTOMY CATHETER (February 25, 1991)
  • K860742 — CAROTID BYPASS SHUNT (May 28, 1986)
  • K860743 — CAROTID BYPASS SHUNT WITH SAMPLING ARM (May 28, 1986)
  • K852704 — TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT (November 26, 1985)
  • K844918 — OCCLUSION & OCCLUSION-IRRIGATION (August 5, 1985)
  • K821220 — MULTILUMEN INTRAVENOUS INFUSION CATHETER (July 9, 1982)
  • K790034 — INTRODUCERS (February 1, 1979)

Other clearances for product code DYG

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  • 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)