# K190941: BioCardia 8.5 F Avance Steerable lntroducer

- Pathway: 510(k) (Traditional)
- Applicant: Biocardia, Inc.
- Decided: May 6, 2019 after 26 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: 2 generations back to K964518 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042623: Agilis Steerable Catheter Introducer, Model 408304, St. Jude Medical, Daig Division, Inc. (2005) Summary page 4.

## Most influential descendants
- K202226: Lim Precision Steerable TS, Steerable Sheath, Dilator (2020), 0 descendants of its own

## Indications for use
The BioCardia 8.5 F Avance Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K190941
Methodology: https://510kreport.com/methodology