# K982187: Fast-Cath Intra-Cardiac Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: Sep 16, 1998 after 86 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 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™ Intra-Cardiac Catheter Introducer: named in the summary without a submission number

## Most influential descendants
- K061015: Fast-Cath Hemostasis Introducer and Transseptal Introducer (2006), 9 descendants of its own
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own
- K151951: Destino Reach (2015), 6 descendants of its own
- K240829: AuST Steerable Sheath (2024), 5 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/K982187
Methodology: https://510kreport.com/methodology