Medical Device Manufacturer · US , Demarest , NJ

Bipore, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1985

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bipore, Inc. Cardiovascular ✕

8 devices

1-8 of 8

Cleared Apr 01, 2008

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Cardiovascular · 117d

Cleared Jan 16, 2008

BIPORE BALLOON DILATION CATHETER

Cardiovascular · 51d

Cleared Dec 07, 2005

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Cardiovascular · 188d

Cleared Jul 09, 2004

BIOPORE BALLOON DILATION CATHETER

Cardiovascular · 56d

Cleared Feb 17, 1999

BIPORE BALLOON DILATATION CATHETER

Cardiovascular · 124d

Cleared Apr 01, 1998

BIPORE BALLOON DILATATION CATHETER

Cardiovascular · 194d

Cleared May 07, 1997

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Cardiovascular · 159d

Cleared Sep 12, 1996

BIPORE BALLOON DILATATION CATHETER

Cardiovascular · 115d