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Reprocessed Femoral Compression Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120204

by Sterilmed, Inc.

Identifiers

510(k) Number
K120204 FDA 510(k)
FDA Product Code
NMF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4450 FDA 510(k)
Regulation Number
870.4450 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Reprocessed Femoral Compression Device by Sterilmed, Inc. — 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
Sterilmed, Inc.

Sources (1)

  • FDA 510(k) K120204 24 fields · synced Jun 18, 2026