Name: Predicase
Price: 199 USD

K-number	K252059
Device name	CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
Applicant	Artivion, Inc.
Product code	OHA
Device class	Class U
Decision date	Oct 2, 2025
Decision	Substantially Equivalent
Regulation	—

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)

Everything you need for a 510(k) submission. Nothing you don't.