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510(k) K020768

3T VESSEL CANNULAS by 3t Medical Systems, LLC — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2002
Date Received
March 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by 3t Medical Systems, LLC

  • K072697 — 3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES (December 20, 2007)
  • K022287 — 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (September 23, 2002)
  • K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (May 3, 2002)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)

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  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
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