# K954610: Model 430-07 Endocardial Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: Dec 16, 1996 after 439 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) Intermedics Model 430-07 Endocardial Pacing Lead: named in the summary without a submission number
- (no number) Intermedics Model 432-03 Endocardial Pacing Lead: named in the summary without a submission number

## Indications for use
The Intermedics leads which are the subject of this 510(k) Notification are endocardial pacing leads designed for use with implantable pulse generators for long-term cardiac pacing. This indication is identical to the indication for use of the legally marketed predicate devices, the Intermedics Models 430-07 and 432-03 Endocardial Pacing Leads. The indications for ventricular pacing include, but are not limited to: sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal atrioventricular (A-V) conduction, the indications for atrial pacing include, but are not limited to: sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony,

Source page: https://510kreport.com/device/K954610
Methodology: https://510kreport.com/methodology