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FDA 510(k)

QXMEDICAL ACCESS & SUPPORT CATHETER

K-Number: K123311 · 2013-01-14

ApplicantQxmedical, LLC
Decision Date2013-01-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

QXMEDICAL ACCESS & SUPPORT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Qxmedical, LLC. It received FDA 510(k) clearance on 2013-01-14 under 510(k) number K123311. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QXMEDICAL ACCESS & SUPPORT CATHETER?

QXMEDICAL ACCESS & SUPPORT CATHETER is a medical device that received FDA 510(k) clearance on 2013-01-14. The listed applicant is Qxmedical, LLC. The 510(k) number is K123311.

When did QXMEDICAL ACCESS & SUPPORT CATHETER receive FDA 510(k) clearance?

QXMEDICAL ACCESS & SUPPORT CATHETER received FDA 510(k) clearance on 2013-01-14, under 510(k) number K123311.

Who is the listed applicant for QXMEDICAL ACCESS & SUPPORT CATHETER?

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

What is the FDA product code for QXMEDICAL ACCESS & SUPPORT CATHETER?

The FDA product code for QXMEDICAL ACCESS & SUPPORT CATHETER is DQY.

Related Clinical Trials

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Other records listing Qxmedical, LLC 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.

K200317Support CatheterK183679Occlusion Balloon CatheterK160561Boosting CatheterK120381Q50 PLUS STENT GRAFT BALLOON CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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