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510(k) K963335

HARMAC BALLOON WEDGE PRESSURE CATHETER by Harmac Medical Products, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1997
Date Received
June 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Harmac Medical Products, Inc.

  • K021916 — HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 (August 29, 2002)
  • K962829 — HARMAC BALLOON ANGIOGRAPHIC CATHETER (October 16, 1997)
  • K962833 — HARMAC TEMPORARY PACING CATHETER WITH BALLOON (October 15, 1997)
  • K963073 — HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET (August 14, 1997)
  • K963336 — HARMAC THERMODILUTION CATHETER (August 14, 1997)
  • K963074 — HARMAC QUADPOLAR MAPPING PACING CATHETER (June 25, 1997)
  • K950895 — HARMAC EXTENSION INFUSION SET (September 1, 1995)

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