DCwire Micro-guidewire

FDA 510(k) K252122 · Shanghai Achieva Medical Suzhou Co., Ltd.

Substantially Equivalent

510(k) numberK252122

Submission

Device name
DCwire Micro-guidewire
Applicant
Shanghai Achieva Medical Suzhou Co., Ltd.
Suzhou, CN
Received
July 7, 2025
Decision date
March 16, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MOF – Guide, Wire, Catheter, Neurovasculature
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

Other 510(k)s with product code MOF

510(k)DeviceApplicantDecision
K26075135 Helix GuidewireMOF · Traditional Piraeus Medical, Inc.08/27/2026SE
K262424Willow 12 GuidewireMOF · Special Arbor Endovascular, LLC08/14/2026SE
K260223Aristotle Mini GuidewireMOF · Traditional Scientia Vascular, Inc.08/06/2026SE
K254006Drivewire 35 GuidewireMOF · Traditional Rapid Medical Ltd.07/17/2026SE
K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional Scientia Vascular, Inc.04/29/2026SE
K252317Zenith Micro GuidewireMOF · Traditional Suzhou Zenith Vascular SciTech Limited04/16/2026SE
K260537Willow 24 GuidewireMOF · Special Arbor Endovascular, LLC03/19/2026SE
K260130Willow 18 GuidewireMOF · Special Arbor Endovascular, LLC02/13/2026SE
K252011CHIKAI Nexus petitMOF · Traditional Asahi Intecc Co., Ltd.02/02/2026SE
K2531680.014” Willow GuidewireMOF · Special Arbor Endovascular, LLC11/26/2025SE

Questions and answers

When was DCwire Micro-guidewire cleared by the FDA?

DCwire Micro-guidewire (K252122) received a 510(k) decision of Substantially Equivalent on March 16, 2026, 252 days after the submission was received.

What is the product code of K252122?

The FDA product code is MOF – Guide, Wire, Catheter, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1330.