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510(k) K982419

HEART-LIFT BALLOON POSITIONER by Cardiothoracic Systems, Inc. — Product Code MWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
July 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stabilizer, Heart
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Cardiothoracic Systems, Inc.

  • K010117 — GUIDANT AXIUS CORONARY SHUNT (April 4, 2001)
  • K983270 — VOYAGER QUAD CANNULA (July 28, 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)

Other clearances for product code MWS

  • K041338 — MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (July 19, 2004)
  • K992476 — PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (September 13, 2000)
  • K992833 — VACUUM ASSIST STABILIZER (November 10, 1999)