# K202226: Lim Precision Steerable TS, Steerable Sheath, Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Heart, Ltd.
- Decided: Dec 15, 2020 after 130 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 K964518 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190941: BioCardia 8.5 F Avance Steerable lntroducer, Biocardia, Inc. (2019) Summary page 4.

## Indications for use
The LIM Precision Steerable TS Transseptal System is indicated 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/K202226
Methodology: https://510kreport.com/methodology