# K073434: Bipore Accuflex Percutaneous Sheath Introducer

- Pathway: 510(k) (Special)
- Applicant: Bipore, Inc.
- Decided: Apr 1, 2008 after 117 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: 3 generations back to K924607 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051513: Bipore Accuflex Percutaneous Sheath Introducer, Bipore, Inc. (2005) Summary page 1.

## Indications for use
The Bipore AccuflexTM Percutaneous Sheath Introducer is recommended for percutaneous introduction of various devices into arteries and/or veins for diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K073434
Methodology: https://510kreport.com/methodology