# Bipore, Inc.

- Location (FDA's records): Northvale, NJ
- FDA decisions: 10 (1985–2008): 10 510(k) clearances
- Product codes: LIT (5), DYB (3), KOZ (1), FIB (1)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Boston Scientific Corp: 2 (https://510kreport.com/company/boston-scientific)
- Arrow Intl., Inc.: 1 (https://510kreport.com/company/arrow-intl)

## Its most-cited devices
- K961980: Bipore Balloon Dilatation Catheter (1996), cited by 2
- K051513: Bipore Accuflex Percutaneous Sheath Introducer (2005), cited by 1
- K964814: Bipore Accuflex Percutaneous Sheath Introducer (1997), cited by 1

## Recent decisions
- K073434: Bipore Accuflex Percutaneous Sheath Introducer (Apr 1, 2008)
- K073318: Bipore Balloon Dilation Catheter (Jan 16, 2008)
- K051513: Bipore Accuflex Percutaneous Sheath Introducer (Dec 7, 2005)
- K041293: Biopore Balloon Dilation Catheter (Jul 9, 2004)
- K983650: Bipore Balloon Dilatation Catheter (Feb 17, 1999)
- K973563: Bipore Balloon Dilatation Catheter (Apr 1, 1998)
- K964814: Bipore Accuflex Percutaneous Sheath Introducer (May 7, 1997)
- K961980: Bipore Balloon Dilatation Catheter (Sep 12, 1996)

Source page: https://510kreport.com/company/bipore