SafetyFix EasyOut System
K-Number: K180753 · 2018-04-20
ApplicantSafetyfix Medical Technologies, Inc.
Decision Date2018-04-20
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SafetyFix EasyOut System is a medical device manufactured by Safetyfix Medical Technologies, Inc.. It received FDA 510(k) clearance on 2018-04-20 under approval 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.
Frequently Asked Questions
What is the SafetyFix EasyOut System?
SafetyFix EasyOut System is a medical device that received FDA 510(k) clearance on 2018-04-20. It is manufactured by Safetyfix Medical Technologies, Inc.. The 510(k) number is K180753.
When was SafetyFix EasyOut System approved by the FDA?
SafetyFix EasyOut System received FDA 510(k) clearance on 2018-04-20, under approval number K180753.
What company makes SafetyFix EasyOut System?
SafetyFix EasyOut System is manufactured by Safetyfix Medical Technologies, Inc..
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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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.