Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart D — Cardiovascular Prosthetic Devices](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices) → [21 CFR 870.3645](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3645) → SJJ — Cardiac Device Identifier

# SJJ · Cardiac Device Identifier

_Cardiovascular · 21 CFR 870.3645 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/SJJ

## Overview

- **Product Code:** SJJ
- **Device Name:** Cardiac Device Identifier
- **Regulation:** [21 CFR 870.3645](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/870.3645)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A cardiac device identifier is a noninvasive device that is intended to provide information about implanted cardiac devices. The device detects and matches telemetry based on manufacturer-specific wireless communication signals,  including radiofrequency or inductive signals, to identify an implanted cardiac device, including manufacturer, model, or type. The device is not intended to deliver therapeutic stimulation to, modify the programming of, or  manipulate the stored data of the implanted device.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN260007](/device/DEN260007.md) | SmartRead(TM) Medical Device Identifier (4100) | BridgeSource Medical Corporation | Sep 29, 2026 | DENG |

## Top Applicants

- BridgeSource Medical Corporation — 1 clearance

---

**Source:** [https://fda-staging.innolitics.com/productcode/SJJ](https://fda-staging.innolitics.com/productcode/SJJ)

**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