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FDA PRODUCT CODE · CLASS II

OWQ — Reprocessed Intravascular Ultrasound Catheter

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
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K254149Sterilmed, Inc. · 510k2026-06-29
K250545Surgical Instrument Service and Savings, Inc. · 510k2025-06-05
K250592Northeast Scientific, Inc. · 510k2025-05-12
K243101Surgical Instrument Service and Savings, Inc. · 510k2025-03-10

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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