FDA 510(k)

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe

Número K: K220981 · 2023-04-20

RequerenteFehling Surgical Instruments, Inc.

Data da decisão2023-04-20

Código do produtoDWP

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe is the device name listed in this FDA 510(k) record. The listed applicant is Fehling Surgical Instruments, Inc.. It received FDA 510(k) clearance on 2023-04-20 under 510(k) number K220981. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe?

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Fehling Surgical Instruments, Inc.. The 510(k) number is K220981.

When did SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe receive FDA 510(k) clearance?

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe received FDA 510(k) clearance on 2023-04-20, under 510(k) number K220981.

Who is the listed applicant for SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe?

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

What is the FDA product code for SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe?

The FDA product code for SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe is DWP.

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Fonte oficial

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