# K040569: Permanent Pacing Lead, Model Refino, Model: Refino-R, RU, Rju

- Pathway: 510(k) (Special)
- Applicant: Oscor, Inc.
- Decided: Apr 7, 2004 after 34 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jan 29, 2008 · Not classified · Z-2333-2008: The O-rings are over tolerance making it hard to connect the leads to the pacemaker.

## Indications for use
Permanent pacing lead, Model Refino TM is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Source page: https://510kreport.com/device/K040569
Methodology: https://510kreport.com/methodology