# K791129: Permanent Lead Intraducer

- Pathway: 510(k) (Traditional)
- Applicant: Daig Corp.
- Decided: Jul 17, 1979 after 33 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K172117: Prelude Pursuit Splittable Sheath Introducer (2017), 2 descendants of its own
- K241334: Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (2025), 1 descendant of its own
- K251186: Bard® Temporary Pacing Electrode Catheter  Needle / Cannula (Introducer) (2025), 0 descendants of its own

## Recalls of this device
- Aug 17, 2009 · Not classified · Z-2229-2009: St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered tha
- Aug 17, 2009 · Not classified · Z-2228-2009: St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered tha
- Jun 24, 2009 · Not classified · Z-1714-2009: St. Jude Medical has initiated a voluntary recall of two lots of Peel Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the outer 
- Jun 24, 2009 · Not classified · Z-1713-2009: St. Jude Medical has initiated a voluntary recall of two lots of Peel l Away Introducers . Isolated lots could contain some items that have been mis-labelled with the incorrect French size of the oute

Source page: https://510kreport.com/device/K791129
Methodology: https://510kreport.com/methodology