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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 the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Zenith Vascular SciTech Limited. It received FDA 510(k) clearance on 2025-07-30 under 510(k) 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. The listed applicant is Suzhou Zenith Vascular SciTech Limited. The 510(k) number is K243534.

When did Micro Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Micro Catheter?

The FDA 510(k) record lists Suzhou Zenith Vascular SciTech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro Catheter?

The FDA product code for Micro Catheter is KRA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05996159Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial FibrillationRECRUITING

Other records listing Suzhou Zenith Vascular SciTech Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253359Zenith Distal Access Long SheathK252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetK252317Zenith Micro Guidewire

Related Devices (Code: KRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, Inc.K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical , Ltd.

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.

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