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FDA 510(k)

OMNIWAVE ENDOVASCULAR SYSTEM

K-Number: K071762 · 2007-09-27

ApplicantOmnisonics Medical Technologies
Decision Date2007-09-27
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNIWAVE ENDOVASCULAR SYSTEM 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 2007-09-27 under 510(k) number K071762. 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 OMNIWAVE ENDOVASCULAR SYSTEM?

OMNIWAVE ENDOVASCULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-27. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K071762.

When did OMNIWAVE ENDOVASCULAR SYSTEM receive FDA 510(k) clearance?

OMNIWAVE ENDOVASCULAR SYSTEM received FDA 510(k) clearance on 2007-09-27, under 510(k) number K071762.

Who is the listed applicant for OMNIWAVE ENDOVASCULAR SYSTEM?

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 OMNIWAVE ENDOVASCULAR SYSTEM?

The FDA product code for OMNIWAVE ENDOVASCULAR SYSTEM is QEY.

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Other records listing Omnisonics Medical Technologies 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.

K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993628OMNISONICS ULTRASONIC PROBESK993445OMNISONIC ENDOSCOPIC DEFLECTOR

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Related Devices (Code: QEY)

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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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