Medtronic Classix Models 8436/8437/8438 - 8438
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K871866 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 Models 8436/8437/8438 are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are intended for patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders.
These models are supplied as reusable, Class III medical devices, regulated under FDA 510(k) clearance (K871866) and the regulation number 870.3610. They are intended for implantation in clinical settings and are not MRI-safe. Storage and handling follow standard sterile medical device protocols, with compliance verified through Medtronic Vascular’s regulatory submissions.
Frequently asked questions
What are the primary clinical uses for the Medtronic Classix Models 8436/8437/8438 pacemaker pulse generators?
These devices are designed to regulate cardiac rhythm by delivering electrical impulses to the heart for patients with chronic bradycardia or conduction disorders. They are intended for long-term implantation to maintain proper heart pacing in clinical settings.
Are the Medtronic Classix Models 8436/8437/8438 devices single-use or reusable?
These devices are classified as reusable, meaning they are intended for repeated use after proper cleaning, sterilization, and maintenance in accordance with Medtronic Vascular’s protocols.
How are these pacemaker pulse generators regulated by the FDA?
The Medtronic Classix Models 8436/8437/8438 are regulated under FDA 510(k) clearance (K871866) and fall under the classification of Class III medical devices, specifically regulated by FDA regulation number 870.3610. They were determined to be substantially equivalent to a predicate device through a traditional 510(k) review process.
What storage and handling precautions should be taken for these devices?
These devices follow standard sterile medical device protocols for storage and handling, as required for implantable devices. Medtronic Vascular’s regulatory submissions confirm compliance with these protocols, ensuring proper sterility and integrity before use.
Are these pacemaker models compatible with MRI procedures?
No, the Medtronic Classix Models 8436/8437/8438 are explicitly noted as not MRI-safe, meaning they should not be used in patients who require MRI imaging.
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: MEDTRONIC CLASSIX MODELS 8436/8437/8438 (K871866) — FDA 510 (k ..., Medtronic Vascular Classix Models 8436/8437/8438 - allmed.wiki, K871866 FDA 510 (k) - MEDTRONIC CLASSIX MODELS 8436/8437/8438, Medtronic Classix Models 8436/8437/8438 510(k) K871866 - fda.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K871866 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K871866 24 fields · synced Oct 6, 2026