Minix, Minix St, New Ic: L74
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K902134 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 MINIX, MINIX ST, and NEW IC: L74 are implantable pacemaker pulse-generators, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when needed. These devices are classified as Class III medical devices under FDA regulations, requiring stringent pre-market approval due to their critical role in managing cardiac arrhythmias.
These pulse-generators are intended for single-use implantation and are regulated under FDA 510(k) clearance (K902134) as substantially equivalent to a predicate device. They are supplied sterile and must be handled in a controlled environment to maintain sterility. The devices are MRI-unsafe and require careful consideration of storage and handling to prevent damage or contamination prior to use.
Frequently asked questions
Are these pacemaker pulse-generators intended for reuse or single-use, and how should they be handled to maintain sterility?
The MINIX, MINIX ST, and NEW IC: L74 pulse-generators are designed for single-use implantation only. They are supplied sterile and must be handled in a controlled, sterile environment to preserve sterility. Since they are not intended for reuse, any unused portion must be discarded following manufacturer guidelines to avoid contamination or damage.
What safety precautions should be taken when storing these devices before implantation?
These devices are MRI-unsafe, meaning they should never be exposed to MRI environments. Storage must be done in a clean, dry environment to prevent physical damage or contamination. Follow the manufacturer’s instructions for packaging and handling to ensure the device remains intact and sterile until use.
How do I determine which model (MINIX, MINIX ST, or NEW IC: L74) is appropriate for my patient’s needs?
The MINIX, MINIX ST, and NEW IC: L74 are all implantable pacemaker pulse-generators designed to regulate heart rhythm by delivering electrical impulses. While the exact clinical differences between the models aren’t specified in the data, the NEW IC: L74 may represent an updated iteration (as suggested by the naming convention). Consult the manufacturer’s technical documentation or a cardiologist to confirm compatibility with your patient’s specific arrhythmia and pacing requirements.
What regulatory pathway was followed for FDA clearance of these devices, and how does that affect their use?
These devices were cleared via the FDA 510(k) pathway (K902134), with a decision of Substantially Equivalent (SESE) to a predicate device. This means they were determined to have the same intended use and technological characteristics as an already-approved pacemaker pulse-generator. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee and falls under product code DXY for implantable pacemakers. Clinicians should confirm compliance with the approved labeling and follow established clinical protocols for implantation.
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 | K902134 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K902134 24 fields · synced Oct 6, 2026