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Bipore, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
7
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K073434BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERApril 1, 2008
K073318BIPORE BALLOON DILATION CATHETERJanuary 16, 2008
K051513BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERDecember 7, 2005
K041293BIOPORE BALLOON DILATION CATHETERJuly 9, 2004
K983650BIPORE BALLOON DILATATION CATHETERFebruary 17, 1999
K973563BIPORE BALLOON DILATATION CATHETERApril 1, 1998
K964814BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCERMay 7, 1997
K961980BIPORE BALLOON DILATATION CATHETERSeptember 12, 1996
K862015O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTERJuly 22, 1986
K844625BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLYJanuary 16, 1985