# K080924: Mond Rvot Stylet Models 4140, 4141, 4150, 4151

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
- Decided: Apr 30, 2008 after 28 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P950022 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960013: Tendril DX Model 1388T & 1388K Endocardial Pacing Leads, Abbott Medical (1997) Summary page 1.
- P950022: TVL (TM) Lead System, Abbott Medical (1996) Summary page 1.

## Indications for use
The CPS Mond™ RVOT Stylets are indicated for: The St. Jude Medical Mond™ RVOT Stylet is designed to place St. Jude Medical right ventricular active fixation leads in the right ventricular outflow tract.

Source page: https://510kreport.com/device/K080924
Methodology: https://510kreport.com/methodology