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FDA 510(k)

Support Catheter

K-Number: K200317 · 2020-05-14

ApplicantQxmedical, LLC
Decision Date2020-05-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2020-05-14 under 510(k) number K200317. 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 Support Catheter?

Support Catheter is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Qxmedical, LLC. The 510(k) number is K200317.

When did Support Catheter receive FDA 510(k) clearance?

Support Catheter received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200317.

Who is the listed applicant for 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 Support Catheter?

The FDA product code for Support Catheter is DQY.

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.

K183679Occlusion Balloon CatheterK160561Boosting 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.

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 CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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