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FDA 510(k)

CLARIVEIN CATHETER

K-Number: K071468 · 2008-03-20

ApplicantVascular Insights, LLC
Decision Date2008-03-20
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLARIVEIN CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Insights, LLC. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K071468. 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 CLARIVEIN CATHETER?

CLARIVEIN CATHETER is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Vascular Insights, LLC. The 510(k) number is K071468.

When did CLARIVEIN CATHETER receive FDA 510(k) clearance?

CLARIVEIN CATHETER received FDA 510(k) clearance on 2008-03-20, under 510(k) number K071468.

Who is the listed applicant for CLARIVEIN CATHETER?

The FDA 510(k) record lists Vascular Insights, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARIVEIN CATHETER?

The FDA product code for CLARIVEIN 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vascular Insights, LLC 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.

K153502ClariVein IC

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.

K253509TriSalus TriNav Advance Infusion SystemTrisalus Life SciencesK254051Extroducer Infusion Catheter SystemSmartWise Sweden ABK261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech Limited

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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