FDA 510(k)

ViewFlex™ X ICE Catheter, Sensor Enabled™

Número K: K251231 · 2025-05-20

Data da decisão2025-05-20

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViewFlex™ X ICE Catheter, Sensor Enabled™ is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2025-05-20 under 510(k) number K251231. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ViewFlex™ X ICE Catheter, Sensor Enabled™?

ViewFlex™ X ICE Catheter, Sensor Enabled™ is a medical device that received FDA 510(k) clearance on 2025-05-20. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K251231.

When did ViewFlex™ X ICE Catheter, Sensor Enabled™ receive FDA 510(k) clearance?

ViewFlex™ X ICE Catheter, Sensor Enabled™ received FDA 510(k) clearance on 2025-05-20, under 510(k) number K251231.

Who is the listed applicant for ViewFlex™ X ICE Catheter, Sensor Enabled™?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewFlex™ X ICE Catheter, Sensor Enabled™?

The FDA product code for ViewFlex™ X ICE Catheter, Sensor Enabled™ is OBJ.

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