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FDA 510(k)

EKOS MICRO-INFUSION SYSTEM

K-Number: K053432 · 2005-12-30

ApplicantEkos Corp.
Decision Date2005-12-30
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

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 2005-12-30 under 510(k) number K053432. 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 EKOS MICRO-INFUSION SYSTEM?

EKOS MICRO-INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Ekos Corp.. The 510(k) number is K053432.

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

EKOS MICRO-INFUSION SYSTEM received FDA 510(k) clearance on 2005-12-30, under 510(k) number K053432.

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 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 MODULATIONK080392EndoWave Infusion SystemK073166ENDOWAVE INFUSION SYSTEMK072507ENDOWAVE INFUSION SYSTEMK071933ENDOWAVE INFUSION SYSTEMK063620EKOS 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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