Medtronic Model 69575 Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K800944 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 69575 is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as hospitals or cardiac care units. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K800944) with a Substantially Equivalent determination. Compliance with MRI safety standards and proper storage conditions are critical for maintaining device integrity.
Frequently asked questions
What is the primary clinical purpose of the Medtronic Model 69575 and who should use it?
The Medtronic Model 69575 is a permanent pacemaker electrode designed to deliver electrical impulses to the heart, helping regulate rhythm in patients with bradycardia or conduction disorders. It is intended for single-use implantation by qualified healthcare professionals, such as cardiologists or electrophysiologists, in clinical settings like hospitals or cardiac care units.
Is this device reusable, or is it meant for one-time use after implantation?
This device is sterile and intended for single-use only. Once implanted, it is not designed to be removed or reused, as it is a permanent pacemaker electrode meant to remain in place long-term to support consistent cardiac pacing.
What storage conditions are required to maintain the integrity of the Medtronic Model 69575 before use?
The device must be stored under controlled conditions to preserve its integrity. While the exact specifications aren’t detailed here, compliance with MRI safety standards is emphasized, and proper storage (likely in a sealed, sterile packaging) is critical to prevent contamination or damage before implantation.
How is this device regulated in the U.S., and what does its classification mean for healthcare providers?
The Medtronic Model 69575 is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K800944) with a *Substantially Equivalent* determination. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee and is deemed safe and effective for its intended use in regulating heart rhythm.
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 | K800944 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K800944 24 fields · synced Oct 6, 2026