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510(k) K231248

Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform by Edwards Lifesciencess, LLC — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2023
Date Received
May 1, 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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  • 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)