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Modified Label For/Spectrax Sxt Implant. Pulse Gen

FDA 510(k)

Class III (US FDA 510(k))

510(k) K862071

by Medtronic Vascular

Identifiers

510(k) Number
K862071 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 Spectrax SXT Implant Pulse Generator is an Implantable Pacemaker Pulse-Generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring pacing support due to bradycardia or other conduction disorders, providing consistent stimulation to maintain proper heart function.

This device is supplied sterile and intended for single-use implantation, adhering to FDA 510(k) clearance (K862071) under regulation 870.3610. It falls under Class III classification and is regulated as a cardiovascular implant. The device is manufactured by Medtronic Vascular and must be handled in sterile conditions prior to surgical 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. Sources consulted: MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT... (K862071) - FDA 510(k), Modified Label For/Spectrax Sxt Implant. Pulse Gen, Modified Label For/spectrax Sxt Implant. Pulse Gen 510 (k) K862071 ..., MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT... (K862071) - FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K862071 24 fields · synced Oct 6, 2026