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CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit …

FDA 510(k)

U (US FDA 510(k))

510(k) K252059

by Artivion, Inc.

Identifiers

510(k) Number
K252059 FDA 510(k)
FDA Product Code
OHA FDA 510(k)

Classification

Device Class
U FDA 510(k)
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit … by Artivion, Inc. — U — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Artivion, Inc.

Sources (1)

  • FDA 510(k) K252059 24 fields · synced Jun 18, 2026