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510(k) K983135

BLOWER/MISTER by Cardiothoracic Systems, Inc. — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1998
Date Received
September 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by Cardiothoracic Systems, Inc.

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  • K982419 — HEART-LIFT BALLOON POSITIONER (January 13, 1999)
  • 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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