Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM

K-Number: K863916 · 1987-01-06

ApplicantCardio-Vascular Innovations, Inc.
Decision Date1987-01-06
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM 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 1987-01-06 under 510(k) number K863916. 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 CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM?

CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Cardio-Vascular Innovations, Inc.. The 510(k) number is K863916.

When did CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM receive FDA 510(k) clearance?

CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863916.

Who is the listed applicant for CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM?

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 CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM?

The FDA product code for CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM 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.

K863917CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.K8527917 FRENCH DUAL LUMEN COM CENT VEIN CATH SYSK843500FRENCH 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

View on FDA Database →

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

↑