← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

OBJ — Catheter, Ultrasound, Intravascular

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

DEVICE CLASS
Class II
REGULATION
21 CFR 870.1200
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
CV
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K252945Conavi Medical, Inc. · 510k2026-04-17
K260816Boston Scientific · 510k2026-04-08
K253399Volcano Corporation (Dba Philips Image Guided Therapy Device · 510k2025-10-28
K250955Yorlabs, Inc. · 510k2025-10-22
K250913Jiangsu Tingsn Technology Co., Ltd. · 510k2025-07-19
K251211ABBOTT MEDICAL · 510k2025-05-23
K251231ABBOTT MEDICAL · 510k2025-05-20
K251103Philips Image Guided Therapy Corporation · 510k2025-05-09

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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