# K964518: Fast-Cath Transseptal Catheter Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: May 14, 1997 after 201 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
92 later devices descend from it; 9 cite it directly.
2 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K042623: Agilis Steerable Catheter Introducer, Model 408304 (2005), 81 descendants of its own
- K061363: Agilis NXT Steerable Introducer (2006), 53 descendants of its own
- K081645: Agilis NXT Steerable Introducer, Model G408324 (2008), 36 descendants of its own
- K052644: Swartz Braided Transseptal Guiding Introducer (2005), 36 descendants of its own
- K022067: Convoy Advanced Delivery Sheath (2002), 13 descendants of its own

## Recalls of this device
- Mar 28, 2012 · Class III · Z-0617-2013: St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as ind
- Oct 5, 2006 · Not classified · Z-0535-2007: Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
- Aug 4, 2004 · Not classified · Z-1426-04: St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inv
- Aug 4, 2004 · Not classified · Z-1425-04: St. Jude Medical received two complaints from customers involving the Telesheath Left Atrial Introducer System side arm detaching from the hub of the inner sheath. Subsequent testing of Telesheath inv

Source page: https://510kreport.com/device/K964518
Methodology: https://510kreport.com/methodology