# K213492: Dib UltraNav Transseptal Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Dib Ultranav Medical, LLC
- Decided: Mar 24, 2022 after 143 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 K013919 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183655: VersaCross Transseptal Sheath, Baylis Medical Company, Inc. (2019) Summary page 4.

## Indications for use
The Dib UltraNav Transseptal Catheter System is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal puncture.

Source page: https://510kreport.com/device/K213492
Methodology: https://510kreport.com/methodology