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FDA 510(k)

EndoWave Infusion System

K-Number: K080392 · 2008-04-30

ApplicantEkos Corp.
Decision Date2008-04-30
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

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 2008-04-30 under 510(k) number K080392. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoWave Infusion System?

EndoWave Infusion System is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Ekos Corp.. The 510(k) number is K080392.

When did EndoWave Infusion System receive FDA 510(k) clearance?

EndoWave Infusion System received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080392.

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 QEY.

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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 MODULATIONK073166ENDOWAVE INFUSION SYSTEMK072507ENDOWAVE INFUSION SYSTEMK071933ENDOWAVE INFUSION SYSTEMK063620EKOS MICRO-INFUSION SYSTEMK062508NEUROWAVE MICRO-INFUSION SYSTEM

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Related Devices (Code: QEY)

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.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

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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