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FDA PRODUCT CODE · CLASS II

LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.5100
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K252116Shanghai MicroPort Medical (Group) Co., Ltd. · 510k2026-04-07
K254022Verge Medical, Inc. · 510k2026-04-02
K252295Terumo Corporation · 510k2026-03-27
K251970Medtronic, Ireland · 510k2026-01-17
K242969Biotronik, Inc. · 510k2024-10-25

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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