Modified Medtronic Classix Model 8438 Pulse Gene.
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K901535 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 Medtronic Classix Model 8438 Pulse Generator is an implantable pacemaker pulse-generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. This device is classified as a Class III medical device under FDA regulations, reflecting its role in life-sustaining or life-supporting functions.
This pulse generator is intended for implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K901535) and falls under the product code DXY, adhering to the regulatory requirements for implantable cardiac devices. Storage and handling must comply with sterile medical device protocols to ensure proper functionality and patient safety.
Frequently asked questions
What is the primary clinical purpose of the Medtronic Classix Model 8438 Pulse Generator, and how does it function in patients?
The Medtronic Classix Model 8438 Pulse Generator is designed to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders by delivering electrical impulses to the heart. It acts as an implantable pacemaker, ensuring consistent contractions when the heart’s natural electrical system fails to do so effectively.
Is this device intended for reuse, or is it meant to be used only once after opening?
This device is supplied sterile for single-use only. Since it is an implantable pulse generator, it must remain uncontaminated to ensure patient safety and proper functionality. Reuse is not recommended or supported by Medtronic.
How should the Medtronic Classix Model 8438 Pulse Generator be stored to maintain sterility and functionality?
The device must be stored according to sterile medical device protocols to preserve its integrity. Since it is sterile upon packaging, it should remain in its original, unopened packaging until implantation. Exposure to moisture, extreme temperatures, or contamination could compromise its performance.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?
The Medtronic Classix Model 8438 Pulse Generator received FDA 510(k) clearance (K901535) under the traditional review process, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same safety and effectiveness standards as a previously approved pacemaker pulse generator, allowing it to be legally marketed and implanted in the U.S.
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 | K901535 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K901535 24 fields · synced Oct 6, 2026