# K964814: Bipore Accuflex Percutaneous Sheath Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Bipore, Inc.
- Decided: May 7, 1997 after 159 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924607 (1993). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924607: Arrow Fischell Kink Resist Percut Sheath Intro Set, Arrow Intl., Inc. (1993) Summary page 1.

## Most influential descendants
- K051513: Bipore Accuflex Percutaneous Sheath Introducer (2005), 1 descendant of its own
- K073434: Bipore Accuflex Percutaneous Sheath Introducer (2008), 0 descendants of its own

## Indications for use
The Bipore AccuFlex™ Percutanous Sheath Introducer is designed to be used for the percutaneous introductionn of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K964814
Methodology: https://510kreport.com/methodology