← Back to catalogue

Minix Models and Minix ST Models

FDA 510(k)

Class III (US FDA 510(k))

510(k) K895495

by Medtronic Vascular

Identifiers

510(k) Number
K895495 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
SESE Substantially Equivalent FDA 510(k)

The device 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 pulse-generators are intended for patients requiring cardiac pacing to correct abnormal heartbeats, including bradycardia or conduction disorders.

This labeling update pertains to existing Minix and Minix ST models and was submitted under FDA 510(k) clearance K895495 as a Substantially Equivalent (SESE) modification. The device is regulated under FDA regulation 870.3610 and falls under the Cardiovascular medical specialty. No additional details on sterility, single-use, or MRI safety are provided in the data.

Frequently asked questions

What is the primary purpose of the Minix and Minix ST implantable pacemaker pulse-generators?

The Minix and Minix ST models are implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. They are intended for patients with bradycardia or conduction disorders who require cardiac pacing to correct abnormal heartbeats.

How were these devices regulated by the FDA, and what type of submission was made?

These devices were regulated under FDA regulation 870.3610 and fall under the Cardiovascular specialty. The labeling update for the Minix and Minix ST models was submitted as a Substantially Equivalent (SESE) modification under FDA 510(k) clearance K895495, filed in 1989. The submission was reviewed by the Cardiovascular (CV) Advisory Committee.

Are these devices single-use or reusable, and is any information provided about sterility?

The provided data does not specify whether the Minix or Minix ST models are single-use or reusable, nor does it include details about sterility. Additional documentation or manufacturer guidelines would be required to determine these specifics.

What types of models or variations are included in this labeling update?

The labeling update specifically pertains to the Minix and Minix ST models of implantable pacemaker pulse-generators. The data lists multiple FEI numbers (e.g., 3002807576, 2017865) associated with these devices, indicating different registrations but not distinguishing between specific model variations beyond the named Minix and Minix ST lines.

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: Add'L Labeling to Minix Models and Minix St Models, K895495 - Add'L Labeling to Minix Models and Minix St Models, Add'l Labeling To Minix Models And Minix St Models… - FDA.report, K894055 - Minix 8341m and Minix St 8331m Pulse Ge...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K895495 24 fields · synced Oct 6, 2026