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Minix 834M & Minix ST 8331M Pulse Generators

FDA 510(k)

Class III (US FDA 510(k))

510(k) K953866

by Medtronic Vascular

Identifiers

510(k) Number
K953866 FDA 510(k)
FDA Product Code
DXY 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
ST FDA 510(k)

The Minix 834M and Minix ST 8331M are implantable pacemaker pulse generators, classified under product code DXY. These devices house a power supply and electronic circuitry designed to generate periodic electrical pulses, stimulating cardiac contraction to maintain proper heart rhythm in patients requiring pacing support.

These pulse generators are intended for surgical implantation and are regulated under FDA 510(k) clearance (K953866) as a Class III device, subject to tracking regulations. They are supplied sterile and intended for single-use implantation, adhering to cardiovascular medical device standards (regulation number 870.3610). No additional context on MRI safety, reusable components, or alternative configurations is provided in the specifications.

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: Minix 834m & Minix St 8331m Pulse Generators (Modification) (K953866 ..., K953866 FDA 510(k) - MINIX 834M & MINIX ST 8331M PULSE GENER..., Minix 834m & Minix St 8331m Pulse Generators (Modification), K953866 FDA 510(k) - MINIX 834M & MINIX ST 8331M PULSE GENER...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K953866 24 fields · synced Oct 6, 2026