# K031210: Model 4951M Myocardial Unipolar Lead

- Pathway: 510(k) (Special)
- Applicant: Metronic, Inc.
- Decided: May 16, 2003 after 29 days
- Product code: DTB (Permanent Pacemaker Electrode)
- Device class: 3
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Model 4951M Lead: named in the summary without a submission number

## Indications for use
The Medtronic Model 495 1M Myocardial, IS- 1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

Source page: https://510kreport.com/device/K031210
Methodology: https://510kreport.com/methodology