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FDA 510(k)

Arterial Catheter

K-Number: K201726 · 2021-07-07

ApplicantHaolang Medical USA Corporation
Decision Date2021-07-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Arterial Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Haolang Medical USA Corporation. It received FDA 510(k) clearance on 2021-07-07 under 510(k) number K201726. 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 Arterial Catheter?

Arterial Catheter is a medical device that received FDA 510(k) clearance on 2021-07-07. The listed applicant is Haolang Medical USA Corporation. The 510(k) number is K201726.

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

Arterial Catheter received FDA 510(k) clearance on 2021-07-07, under 510(k) number K201726.

Who is the listed applicant for Arterial Catheter?

The FDA 510(k) record lists Haolang Medical USA Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arterial Catheter?

The FDA product code for Arterial Catheter is DQY.

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.

NCT07179705Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU PatientsRECRUITING

Other records listing Haolang Medical USA Corporation 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.

K241581Hemodialysis CatheterK201697Umbilical Vessels 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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