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FDA PRODUCT CODE · CLASS II

OZT — Balloon Aortic Valvuloplasty

A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1255
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K253855Intervention Tech, Inc. ; dba Corvention · 510k2026-05-06
K260437Dongguan TT Medical, Inc. · 510k2026-03-20
K241562Disa Medinotec · 510k2025-03-11

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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