# K973840: Fast-Cath (TM) Intra-Cardiac Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: May 21, 1998 after 225 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
83 later devices descend from it; 3 cite it directly.
2 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fast-Cath™ Transseptal Catheter Introducer: named in the summary without a submission number

## 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
- K070417: Across Transseptal Access System, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984 (2007), 11 descendants of its own

## Recalls of this device
- 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

## Indications for use
The Fast-Cath™ Intra-Cardiac Introducer is indicated for use when introducing various cardiovascular catheters or biopsy devices into the heart.

Source page: https://510kreport.com/device/K973840
Methodology: https://510kreport.com/methodology