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FDA 510(k)

NEUROEDGE INFUSION CATHETER

K-Number: K011646 · 2001-08-27

ApplicantNeuro Vasx, Inc.
Decision Date2001-08-27
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEUROEDGE INFUSION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Vasx, Inc.. It received FDA 510(k) clearance on 2001-08-27 under 510(k) number K011646. 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 NEUROEDGE INFUSION CATHETER?

NEUROEDGE INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Neuro Vasx, Inc.. The 510(k) number is K011646.

When did NEUROEDGE INFUSION CATHETER receive FDA 510(k) clearance?

NEUROEDGE INFUSION CATHETER received FDA 510(k) clearance on 2001-08-27, under 510(k) number K011646.

Who is the listed applicant for NEUROEDGE INFUSION CATHETER?

The FDA 510(k) record lists Neuro Vasx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROEDGE INFUSION CATHETER?

The FDA product code for NEUROEDGE INFUSION 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 Neuro Vasx, Inc. 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.

K984258NEUROVASX SUB-MICROINFUSION CATHETER

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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