FDA 510(k)

OPUSWAVE Dual Sensor Imaging System

Número K: K250684 · 2025-07-02

RequerenteTerumo Cardiovascular Systems Thi Plant

Data da decisão2025-07-02

Código do produtoNQQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

OPUSWAVE Dual Sensor Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Thi Plant. It received FDA 510(k) clearance on 2025-07-02 under 510(k) number K250684. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OPUSWAVE Dual Sensor Imaging System?

OPUSWAVE Dual Sensor Imaging System is a medical device that received FDA 510(k) clearance on 2025-07-02. The listed applicant is Terumo Cardiovascular Systems Thi Plant. The 510(k) number is K250684.

When did OPUSWAVE Dual Sensor Imaging System receive FDA 510(k) clearance?

OPUSWAVE Dual Sensor Imaging System received FDA 510(k) clearance on 2025-07-02, under 510(k) number K250684.

Who is the listed applicant for OPUSWAVE Dual Sensor Imaging System?

The FDA 510(k) record lists Terumo Cardiovascular Systems Thi Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPUSWAVE Dual Sensor Imaging System?

The FDA product code for OPUSWAVE Dual Sensor Imaging System is NQQ.

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