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510(k) K010117

GUIDANT AXIUS CORONARY SHUNT by Cardiothoracic Systems, Inc. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2001
Date Received
January 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by Cardiothoracic Systems, Inc.

  • K983270 — VOYAGER QUAD CANNULA (July 28, 1999)
  • 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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  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
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