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FDA 510(k)

Cordis BRITECROSS Support Catheter

K-Number: K233637 · 2024-06-28

ApplicantCordis US Corp
Decision Date2024-06-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cordis BRITECROSS Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K233637. 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 Cordis BRITECROSS Support Catheter?

Cordis BRITECROSS Support Catheter is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Cordis US Corp. The 510(k) number is K233637.

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

Cordis BRITECROSS Support Catheter received FDA 510(k) clearance on 2024-06-28, under 510(k) number K233637.

Who is the listed applicant for Cordis BRITECROSS Support Catheter?

The FDA 510(k) record lists Cordis US Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cordis BRITECROSS Support Catheter?

The FDA product code for Cordis BRITECROSS Support 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.

NCT03923387Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure DeviceCOMPLETEDNCT07246902Mobilization and Outcomes After Venous ClosureACTIVE_NOT_RECRUITING

Other records listing Cordis US Corp 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.

PMA P100013Device, hemostasis, vascularPMA P030047Stent, carotidPMA P040044Device, hemostasis, vascularPMA P120002STENT, SUPERFICIAL FEMORAL ARTERYPMA P020036STENT, ILIACPMA P150002SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

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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

View on FDA Database →

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

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