← Product Code [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY) · K841983

# COOK PACEMAKER 216 BIPOLAR CARDIAC - (K841983)

_Cook Pacemaker Corp. · DXY · Jul 11, 1984 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K841983

## Device Facts

- **Applicant:** Cook Pacemaker Corp.
- **Product Code:** [DXY](/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY.md)
- **Decision Date:** Jul 11, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.3610
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device may include triggered, inhibited, and asynchronous modes and is implanted in the human body.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K841983](https://fda.innolitics.com/submissions/CV/subpart-d%E2%80%94cardiovascular-prosthetic-devices/DXY/K841983)

**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