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510(k) K072697

3T BLOOD COLLECTION CARDIOTOMY RESERVOIRS AND ACCESSORIES by 3t Medical Systems, LLC — Product Code DTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
September 24, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by 3t Medical Systems, LLC

  • K022287 — 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS (September 23, 2002)
  • K020768 — 3T VESSEL CANNULAS (August 23, 2002)
  • K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (May 3, 2002)
  • K001245 — 3T L. V. CONTROL VALVE (August 15, 2001)

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