Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3710](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3710) → KFJ — Materials, Repair Or Replacement, Pacemaker

# KFJ · Materials, Repair Or Replacement, Pacemaker

_Cardiovascular · 21 CFR 870.3710 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ

## Overview

- **Product Code:** KFJ
- **Device Name:** Materials, Repair Or Replacement, Pacemaker
- **Regulation:** [21 CFR 870.3710](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3710)
- **Device Class:** 3
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **Implant:** yes

## Identification

A pacemaker repair or replacement material is an adhesive, a sealant, a screw, a crimp, or any other material used to repair a pacemaker lead or to reconnect a pacemaker lead to a pacemaker pulse generator.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K913919](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K913919.md) | UNIVERSAL TERMINAL CAP, 3.2MM | Telectronics Pacing Systems, Inc. | Dec 31, 1991 | SESE |
| [K852236](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K852236.md) | MEDTRONIC MODEL 5867-1A | Medtronic Vascular | Jul 11, 1985 | SESE |
| [K813518](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ/K813518.md) | IMPLANT AID SPLICING CRIMP & SLEEVE | Intermedics, Inc. | Jan 12, 1982 | SESE |

## Top Applicants

- Intermedics, Inc. — 1 clearance
- Medtronic Vascular — 1 clearance
- Telectronics Pacing Systems, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/KFJ)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com