# K090867: Airbloc Transseptal Introducer, 53 CM, Model FA001, Airblock Transseptal Introducer, 72 CM ,Model FA002

- Pathway: 510(k) (Traditional)
- Applicant: Ep Dynamics, Inc.
- Decided: Jul 30, 2009 after 121 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EP Dynamics, Inc. AirBloc TM Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K090867
Methodology: https://510kreport.com/methodology