Medtronic Model 6972 Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K790462 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 6972 is a permanent pacemaker electrode, classified as a Class 3 device under FDA regulations. It is designed to be implanted within the cardiovascular system to facilitate cardiac pacing, ensuring proper electrical signaling for heart function.
This device is supplied sterile and intended for single-use implantation by qualified medical professionals. It is regulated under FDA 510(k) clearance (K790462) and falls under the product code DTB. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.
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 Model 6972 - Medtronic Vascular | FDA Evidence Review, MEDTRONIC MODEL 6972 (K790462) - FDA 510 (k), MEDTRONIC MODEL 6972 (K790462) — FDA 510(k) | Innolitics, PDF K790462 - Medtronic Model 6972, Peripheral vascular health products - Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K790462 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K790462 24 fields · synced Oct 6, 2026