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510(k) K963074

HARMAC QUADPOLAR MAPPING PACING CATHETER by Harmac Medical Products, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1997
Date Received
June 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Harmac Medical Products, Inc.

  • K021916 — HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001 (August 29, 2002)
  • K963335 — HARMAC BALLOON WEDGE PRESSURE CATHETER (October 16, 1997)
  • 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)
  • K950895 — HARMAC EXTENSION INFUSION SET (September 1, 1995)

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