# K962174: Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: Aug 21, 1996 after 77 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: 2 generations back to K902672 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890412: Models 430-07 & 431-07 Implantable Pacing Leads, Intermedics, Inc. (1989) Summary page 6.
- K902672: Intermedics 430-07 Bipol Implant Endocard Pac Lead, Intermedics, Inc. (1991) Summary page 6.
- K954719: Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing Lead, Intermedics, Inc. (1996) Summary page 6.
- K890411: Models 432-03 & 433-03 Implantable Pacing Leads, Intermedics, Inc. (1989) Summary page 6.
- K912235: Models 432-03 & 433-03 Implant Endocard Pac Lead, Intermedics, Inc. (1991) Summary page 6.
- K883602: Biopore VS.1 Endocardial Inter Implant Pacing Lead, Intermedics, Inc. (1988) Summary page 6.
- K922972: Models 438-05 and 435-05 Implantable Pacing Lead, Intermedics, Inc. (1993) Summary page 6.
- K955550: Cardifix EZ Bipolar/Unipolar Endocardial Pacing Lead, Intermedics, Inc. (1996). Cleared while this submission was under review Summary page 6.

## Cited in the summary but kept off the family tree
- K954610: Model 430-07 Endocardial Pacing Lead, Intermedics, Inc. (1996). Our OCR of the scanned summary read K954610, which FDA decided on Dec 16, 1996, after this device was decided (Aug 21, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 6.
- K955122: Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing Lead, Intermedics, Inc. (1996). Our OCR of the scanned summary read K955122, which FDA decided on Nov 4, 1996, after this device was decided (Aug 21, 1996), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 6.

## Indications for use
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, 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. 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. 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.

Source page: https://510kreport.com/device/K962174
Methodology: https://510kreport.com/methodology