FDA 510(k)

SafetyFix EasyOut System

Número K: K180753 · 2018-04-20

RequerenteSafetyfix Medical Technologies, Inc.

Data da decisão2018-04-20

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SafetyFix EasyOut System is the device name listed in this FDA 510(k) record. The listed applicant is Safetyfix Medical Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180753. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SafetyFix EasyOut System?

SafetyFix EasyOut System is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Safetyfix Medical Technologies, Inc.. The 510(k) number is K180753.

When did SafetyFix EasyOut System receive FDA 510(k) clearance?

SafetyFix EasyOut System received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180753.

Who is the listed applicant for SafetyFix EasyOut System?

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

What is the FDA product code for SafetyFix EasyOut System?

The FDA product code for SafetyFix EasyOut System is HWC. This falls under the Cardiovascular category.

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