Medtronic Models 8432/8433/8434 Pacemaker Pulse - 8433
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K844958 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
- Models / Variants
- 8432 FDA 510(k)8433 FDA 510(k)8434 - Pacemaker Pulse FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Models 8432/8433/8434 Pacemaker Pulse is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. These devices are intended for patients with bradycardia or other conduction disorders requiring chronic cardiac pacing.
Supplied as a reusable, implantable device, the pulse-generator is regulated under FDA 510(k) clearance (K844958) and falls under the Cardiovascular advisory committee classification. Manufactured by Medtronic Vascular, it adheres to regulatory standards outlined in 21 CFR 870.3610, with a decision of Substantially Equivalent granted in 1985. Models 8432/8433/8434 are intended for surgical implantation and require sterile handling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K844958 - Medtronic Models 8432/8433/8434 - Pacemaker Pulse, Medtronic Models 8432/8433/8434 - Pacemaker Pulse, Medtronic Vascular Models 8432/8433/8434 - Pacemaker Pulse, Medtronic Models 8432/8433/8434 - Pacemaker Pulse… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K844958 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K844958 24 fields · synced Oct 6, 2026