# K181031: TSI Transseptal Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Pressure Products Medical Device Manufacturing, LLC
- Decided: Oct 26, 2018 after 191 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964518 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964518: Fast-Cath Transseptal Catheter Introducer, Daig Corp. (1997) Summary page 4.

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0852-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
The Transseptal Introducer is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Transseptal Introducer is intended for single use only.

Source page: https://510kreport.com/device/K181031
Methodology: https://510kreport.com/methodology