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Harmac Medical Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
12
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K021916HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001August 29, 2002
K963335HARMAC BALLOON WEDGE PRESSURE CATHETEROctober 16, 1997
K962829HARMAC BALLOON ANGIOGRAPHIC CATHETEROctober 16, 1997
K962833HARMAC TEMPORARY PACING CATHETER WITH BALLOONOctober 15, 1997
K963336HARMAC THERMODILUTION CATHETERAugust 14, 1997
K963073HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLETAugust 14, 1997
K963074HARMAC QUADPOLAR MAPPING PACING CATHETERJune 25, 1997
K950895HARMAC EXTENSION INFUSION SETSeptember 1, 1995