MiniX/MiniX ST Pulse Generators
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K932884 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
- SESP Substantially Equivalent — Postmarket Surveillance FDA 510(k)
The MiniX/MiniX ST Pulse Generators are implantable pacemaker pulse-generators, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. These devices are classified as Class III medical devices under FDA regulations, requiring pre-market approval due to their critical role in managing life-threatening cardiac conditions.
These pulse generators are supplied sterile and intended for single-use implantation, though specific models may vary in design and functionality. They are regulated under FDA 510(k) clearance (K932884) and fall under the product code DXY, adhering to the regulation number 870.3610. Storage and handling must comply with sterile medical device protocols to ensure patient safety and device efficacy.
Frequently asked questions
Are the MiniX/MiniX ST Pulse Generators designed for reuse or single-use implantation, and how should they be handled to maintain sterility?
The MiniX/MiniX ST Pulse Generators are supplied sterile and intended for single-use implantation. Since they are classified as sterile medical devices, proper sterile handling and storage protocols must be followed to ensure patient safety and device efficacy. This includes maintaining sterile packaging until the time of use and adhering to standard sterile medical device preparation guidelines.
What types of cardiac conditions are these pulse generators intended to address, and how do they function?
These devices are designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. They function as implantable pacemaker pulse-generators, delivering controlled electrical impulses to the heart to maintain a proper heartbeat when the natural conduction system fails.
What regulatory pathway was followed for FDA clearance of the MiniX/MiniX ST Pulse Generators, and what product code is associated with them?
The MiniX/MiniX ST Pulse Generators received FDA 510(k) clearance under the traditional review pathway, with the clearance number K932884. They fall under product code DXY and are regulated under FDA regulation number 870.3610, which pertains to implantable pacemaker pulse-generators.
How many distinct models or variations of the MiniX/MiniX ST Pulse Generators have been registered with the FDA, and what is their classification?
The FDA records multiple registration numbers (e.g., 2017865, 3005334138, etc.) associated with this device, indicating several distinct models or variations. These devices are classified as Class III, requiring pre-market approval due to their critical role in managing life-threatening cardiac conditions.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K932884 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K932884 24 fields · synced Oct 6, 2026