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510(k) K193466

Swan-Ganz Catheters by Edwards Lifesciences, LLC — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2020
Date Received
December 16, 2019
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

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  • 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)