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510(k) K983270

VOYAGER QUAD CANNULA by Cardiothoracic Systems, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1999
Date Received
September 17, 1998
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 Cardiothoracic Systems, Inc.

  • K010117 — GUIDANT AXIUS CORONARY SHUNT (April 4, 2001)
  • K982419 — HEART-LIFT BALLOON POSITIONER (January 13, 1999)
  • K983135 — BLOWER/MISTER (November 13, 1998)
  • K963965 — CTS MIDCAB STITCHER (March 17, 1998)
  • K970638 — CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT (October 30, 1997)
  • K963503 — CTS MIDCAB CORONARY SHUNT (April 3, 1997)
  • K963930 — CTS MIDCAB/SVH BIPOLAR SCISSORS (January 16, 1997)

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