Synxess Neurovascular Guidewire
K-Number: K240871 · 2024-11-18
Decision Date2024-11-18
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Synxess Neurovascular Guidewire is a medical device manufactured by Enlight Medical Technologies (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-11-18 under approval number K240871. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Synxess Neurovascular Guidewire?
Synxess Neurovascular Guidewire is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Enlight Medical Technologies (Shenzhen) Co., Ltd.. The 510(k) number is K240871.
When was Synxess Neurovascular Guidewire approved by the FDA?
Synxess Neurovascular Guidewire received FDA 510(k) clearance on 2024-11-18, under approval number K240871.
What company makes Synxess Neurovascular Guidewire?
Synxess Neurovascular Guidewire is manufactured by Enlight Medical Technologies (Shenzhen) Co., Ltd..
What is the FDA product code for Synxess Neurovascular Guidewire?
The FDA product code for Synxess Neurovascular Guidewire is MOF.
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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.