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FDA 510(k)

EKOS MICRO-INFUSION SYSTEM

K-Number: K051225 · 2005-06-10

ApplicantEkos Corp.
Decision Date2005-06-10
Product CodeNUI
Advisory CommitteeCV
DecisionUnknown

Device Summary

EKOS MICRO-INFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ekos Corp.. It received FDA 510(k) clearance on 2005-06-10 under 510(k) number K051225. The device is classified under product code NUI. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EKOS MICRO-INFUSION SYSTEM?

EKOS MICRO-INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-06-10. The listed applicant is Ekos Corp.. The 510(k) number is K051225.

When did EKOS MICRO-INFUSION SYSTEM receive FDA 510(k) clearance?

EKOS MICRO-INFUSION SYSTEM received FDA 510(k) clearance on 2005-06-10, under 510(k) number K051225.

Who is the listed applicant for EKOS MICRO-INFUSION SYSTEM?

The FDA 510(k) record lists Ekos Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EKOS MICRO-INFUSION SYSTEM?

The FDA product code for EKOS MICRO-INFUSION SYSTEM is NUI.

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 Ekos Corp. 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.

K081467EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATIONK080392EndoWave Infusion SystemK073166ENDOWAVE INFUSION SYSTEMK072507ENDOWAVE INFUSION SYSTEMK071933ENDOWAVE INFUSION SYSTEMK063620EKOS MICRO-INFUSION SYSTEM

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Related Devices (Code: NUI)

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.

K062508NEUROWAVE MICRO-INFUSION SYSTEMEkos Corp.K053437EKOS MICRO-INFUSION SYSTEMEkos Corp.K041826EKOS ULTRASOUND INFUSION SYSTEMEkos Corp.

Official Source

View on FDA Database →

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

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