FDA 510(k)

Micro Catheter

K-Number: K243534 · 2025-07-30

ApplicantSuzhou Zenith Vascular SciTech Limited

Decision Date2025-07-30

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Micro Catheter is a medical device manufactured by Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2025-07-30 under approval number K243534. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro Catheter?

Micro Catheter is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K243534.

When was Micro Catheter approved by the FDA?

Micro Catheter received FDA 510(k) clearance on 2025-07-30, under approval number K243534.

What company makes Micro Catheter?

Micro Catheter is manufactured by Suzhou Zenith Vascular SciTech Limited.

What is the FDA product code for Micro Catheter?

The FDA product code for Micro Catheter is KRA.

Related Clinical Trials

NCT05996159 Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation RECRUITING

Other Devices by Suzhou Zenith Vascular SciTech Limited

K252317Zenith Micro Guidewire

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.