FDA 510(k)

Signal Catheter

Número K: K182635 · 2019-01-10

Data da decisão2019-01-10

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Signal Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Safe Medical Design. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K182635. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Signal Catheter?

Signal Catheter is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Safe Medical Design. The 510(k) number is K182635.

When did Signal Catheter receive FDA 510(k) clearance?

Signal Catheter received FDA 510(k) clearance on 2019-01-10, under 510(k) number K182635.

Who is the listed applicant for Signal Catheter?

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

What is the FDA product code for Signal Catheter?

The FDA product code for Signal Catheter is EZL.

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