FDA 510(k)

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter

Número K: K241540 · 2024-06-28

Data da decisão2024-06-28

Código do produtoOBJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K241540. 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 NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter?

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K241540.

When did NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter receive FDA 510(k) clearance?

NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter received FDA 510(k) clearance on 2024-06-28, under 510(k) number K241540.

Who is the listed applicant for NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter?

The FDA 510(k) record lists Biosense Webster, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter?

The FDA product code for NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter is OBJ.

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