# K955550: Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: Jun 19, 1996 after 197 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
Longest line of descent: 1 generation back to K902672 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922972: Models 438-05 and 435-05 Implantable Pacing Lead, Intermedics, Inc. (1993) Summary page 4.
- K954719: Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead, Intermedics, Inc. (1996). Cleared while this submission was under review Summary page 4.
- K902672: Intermedics 430-07 Bipol Implant Endocard Pac Lead, Intermedics, Inc. (1991) Summary page 4.

## Most influential descendants
- K962174: Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) (1996), 0 descendants of its own

## Indications for use
The models 438-07 and 435-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. 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 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. Active-fixation leads are specifically indicated for use in cases where passive-fixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease. 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/K955550
Methodology: https://510kreport.com/methodology