Home / 510(k) Clearances / K233983

510(k) K233983

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) by Edwards Lifesciences — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2024
Date Received
December 18, 2023
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

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Other clearances for product code DYG

  • K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe (December 9, 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)
  • K012225 — ATTAIN 6215 VENOGRAM BALLOON CATHETER (August 28, 2001)