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FDA 510(k)

QUANTIX/OR DEVICE

K-Number: K030357 · 2003-08-20

ApplicantCardiosonix, Ltd.
Decision Date2003-08-20
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QUANTIX/OR 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 2003-08-20 under 510(k) number K030357. 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 DEVICE?

QUANTIX/OR DEVICE is a medical device that received FDA 510(k) clearance on 2003-08-20. The listed applicant is Cardiosonix, Ltd.. The 510(k) number is K030357.

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

QUANTIX/OR DEVICE received FDA 510(k) clearance on 2003-08-20, under 510(k) number K030357.

Who is the listed applicant for QUANTIX/OR 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 DEVICE?

The FDA product code for QUANTIX/OR 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.

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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.

K041180QUANTIX OR VESSEL STABILIZER 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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