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Medtronic A-V Pacing System Analyzer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K812262

by Medtronic Vascular

Identifiers

510(k) Number
K812262 FDA 510(k)
FDA Product Code
DTC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3630 FDA 510(k)
Regulation Number
870.3630 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Medtronic A-V Pacing System Analyzer by Medtronic Vascular — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K812262 24 fields · synced Jun 18, 2026