Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM

K-Number: K083335 · 2008-12-15

ApplicantOmnisonics Medical Technologies
Decision Date2008-12-15
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED 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 2008-12-15 under 510(k) number K083335. 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 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM?

MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-15. The listed applicant is Omnisonics Medical Technologies. The 510(k) number is K083335.

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

MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM received FDA 510(k) clearance on 2008-12-15, under 510(k) number K083335.

Who is the listed applicant for MODIFIED 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 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM?

The FDA product code for MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM is QEY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K071762OMNIWAVE ENDOVASCULAR SYSTEMK052428RESOLUTION ENDOVASCULAR SYSTEMK041705RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2K003824OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STIK993628OMNISONICS ULTRASONIC PROBESK993445OMNISONIC ENDOSCOPIC DEFLECTOR

View all 8 devices →

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.

↑