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FDA 510(k)

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters

Número K: K231015 · 2024-07-01

RequerenteInnovative Health, LLC
Data da decisão2024-07-01
Código do produtoNLI
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K231015. The device is classified under product code NLI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Innovative Health, LLC. The 510(k) number is K231015.

When did Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters receive FDA 510(k) clearance?

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters received FDA 510(k) clearance on 2024-07-01, under 510(k) number K231015.

Who is the listed applicant for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

The FDA product code for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is NLI.

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