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Xro Umbilical Catheter-Code 270

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851005

by Vygon Corp.

Identifiers

510(k) Number
K851005 FDA 510(k)
FDA Product Code
FOS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5200 FDA 510(k)
Regulation Number
880.5200 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Xro Umbilical Catheter-Code 270 by Vygon Corp. — 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
Vygon Corp.

Sources (1)

  • FDA 510(k) K851005 24 fields · synced Jun 18, 2026