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FDA 510(k)

RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2

K-Number: K041705 · 2004-09-01

ApplicantOmnisonics Medical Technologies
Decision Date2004-09-01
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 is the device name listed in this FDA 510(k) record. The listed applicant is Omnisonics Medical Technologies. It received FDA 510(k) clearance on 2004-09-01 under 510(k) number K041705. 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 RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2?

RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 is a medical device that received FDA 510(k) clearance on 2004-09-01. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K041705.

When did RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 receive FDA 510(k) clearance?

RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 received FDA 510(k) clearance on 2004-09-01, under 510(k) number K041705.

Who is the listed applicant for RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2?

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

What is the FDA product code for RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2?

The FDA product code for RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2 is QEY.

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Other records listing Omnisonics Medical Technologies as applicant

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K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK071762OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993628OMNISONICS ULTRASONIC PROBESK993445OMNISONIC ENDOSCOPIC DEFLECTOR

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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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