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FDA 510(k)

7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS

K-Number: K852791 · 1985-11-05

ApplicantCardio-Vascular Innovations, Inc.
Decision Date1985-11-05
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Vascular Innovations, Inc.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K852791. 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 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS?

7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Cardio-Vascular Innovations, Inc.. The 510(k) number is K852791.

When did 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS receive FDA 510(k) clearance?

7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS received FDA 510(k) clearance on 1985-11-05, under 510(k) number K852791.

Who is the listed applicant for 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS?

The FDA 510(k) record lists Cardio-Vascular Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS?

The FDA product code for 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cardio-Vascular Innovations, Inc. 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.

K863916CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEMK863917CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.K843500FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN

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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