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FDA PRODUCT CODE · CLASS III

SDZ — Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions

Endovascular Repair of Ascending Aorta and Aortic Arch Lesions

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P250033Endospan , Ltd. · pma2026-05-20
P210032W. L. Gore & Associates, Inc. · pma2025-04-11

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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