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FDA 510(k)

QUANTIX OR VESSEL STABILIZER DEVICE

K-Number: K041180 · 2004-06-07

ApplicantCardiosonix, Ltd.
Decision Date2004-06-07
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIX OR VESSEL STABILIZER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiosonix, Ltd.. It received FDA 510(k) clearance on 2004-06-07 under 510(k) number K041180. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUANTIX OR VESSEL STABILIZER DEVICE?

QUANTIX OR VESSEL STABILIZER DEVICE is a medical device that received FDA 510(k) clearance on 2004-06-07. The listed applicant is Cardiosonix, Ltd.. The 510(k) number is K041180.

When did QUANTIX OR VESSEL STABILIZER DEVICE receive FDA 510(k) clearance?

QUANTIX OR VESSEL STABILIZER DEVICE received FDA 510(k) clearance on 2004-06-07, under 510(k) number K041180.

Who is the listed applicant for QUANTIX OR VESSEL STABILIZER DEVICE?

The FDA 510(k) record lists Cardiosonix, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIX OR VESSEL STABILIZER DEVICE?

The FDA product code for QUANTIX OR VESSEL STABILIZER DEVICE is DPW.

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 Cardiosonix, Ltd. 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.

K030357QUANTIX/OR DEVICEK023431QUANTIX/ND DEVICE

Related Devices (Code: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington Medical, Inc.

Official Source

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