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FDA 510(k)

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.

K-Number: K863917 · 1987-01-06

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

Device Summary

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER 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 1987-01-06 under 510(k) number K863917. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.?

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. 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 K863917.

When did CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. receive FDA 510(k) clearance?

CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863917.

Who is the listed applicant for CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER 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 CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.?

The FDA product code for CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. is DYB.

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 SYSTEMK8527917 FRENCH DUAL LUMEN COM CENT VEIN CATH SYSK843500FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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