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FDA 510(k)

IVS INTRODUCER SET, MODEL 1003

K-Number: K030723 · 2003-04-03

ApplicantIntegrated Vascular Systems, Inc.
Decision Date2003-04-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IVS INTRODUCER SET, MODEL 1003 is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Vascular Systems, Inc.. It received FDA 510(k) clearance on 2003-04-03 under 510(k) number K030723. 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 IVS INTRODUCER SET, MODEL 1003?

IVS INTRODUCER SET, MODEL 1003 is a medical device that received FDA 510(k) clearance on 2003-04-03. The listed applicant is Integrated Vascular Systems, Inc.. The 510(k) number is K030723.

When did IVS INTRODUCER SET, MODEL 1003 receive FDA 510(k) clearance?

IVS INTRODUCER SET, MODEL 1003 received FDA 510(k) clearance on 2003-04-03, under 510(k) number K030723.

Who is the listed applicant for IVS INTRODUCER SET, MODEL 1003?

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

What is the FDA product code for IVS INTRODUCER SET, MODEL 1003?

The FDA product code for IVS INTRODUCER SET, MODEL 1003 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 Integrated Vascular Systems, 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.

K031583MODIFICATION TO IVS INTRODUCER SET, MODEL 1003K020879IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER); IVS INTRUDUCER SET, MODEL 1001

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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