DCwire Micro-guidewire
K-Number: K252122 · 2026-03-16
Decision Date2026-03-16
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
DCwire Micro-guidewire is a medical device manufactured by Shanghai Achieva Medical Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval number K252122. 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 DCwire Micro-guidewire?
DCwire Micro-guidewire is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Shanghai Achieva Medical Suzhou Co., Ltd.. The 510(k) number is K252122.
When was DCwire Micro-guidewire approved by the FDA?
DCwire Micro-guidewire received FDA 510(k) clearance on 2026-03-16, under approval number K252122.
What company makes DCwire Micro-guidewire?
DCwire Micro-guidewire is manufactured by Shanghai Achieva Medical Suzhou Co., Ltd..
What is the FDA product code for DCwire Micro-guidewire?
The FDA product code for DCwire Micro-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.