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FDA 510(k)

ENDOWAVE INFUSION SYSTEM

K-Number: K073166 · 2008-04-22

ApplicantEkos Corp.
Decision Date2008-04-22
Product CodeKRA
Advisory CommitteeCV
DecisionUnknown

Device Summary

ENDOWAVE 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 2008-04-22 under 510(k) number K073166. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ENDOWAVE INFUSION SYSTEM?

ENDOWAVE INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-22. The listed applicant is Ekos Corp.. The 510(k) number is K073166.

When did ENDOWAVE INFUSION SYSTEM receive FDA 510(k) clearance?

ENDOWAVE INFUSION SYSTEM received FDA 510(k) clearance on 2008-04-22, under 510(k) number K073166.

Who is the listed applicant for ENDOWAVE 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 ENDOWAVE INFUSION SYSTEM?

The FDA product code for ENDOWAVE INFUSION SYSTEM is KRA.

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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 SystemK072507ENDOWAVE INFUSION SYSTEMK071933ENDOWAVE INFUSION SYSTEMK063620EKOS MICRO-INFUSION SYSTEMK062508NEUROWAVE MICRO-INFUSION SYSTEM

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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

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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