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FDA 510(k)

LYSUS INFUSION SYSTEM

K-Number: K050472 · 2005-03-11

ApplicantEkos Corp.
Decision Date2005-03-11
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LYSUS 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 2005-03-11 under 510(k) number K050472. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYSUS INFUSION SYSTEM?

LYSUS INFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-03-11. The listed applicant is Ekos Corp.. The 510(k) number is K050472.

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

LYSUS INFUSION SYSTEM received FDA 510(k) clearance on 2005-03-11, under 510(k) number K050472.

Who is the listed applicant for LYSUS 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 LYSUS INFUSION SYSTEM?

The FDA product code for LYSUS INFUSION SYSTEM is DRA.

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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: DRA)

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.

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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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