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)

IVT INTRODUCER SHEATH

K-Number: K903463 · 1991-01-03

ApplicantIntensive Technology, Inc.
Decision Date1991-01-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IVT INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1991-01-03 under 510(k) number K903463. 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 IVT INTRODUCER SHEATH?

IVT INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1991-01-03. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K903463.

When did IVT INTRODUCER SHEATH receive FDA 510(k) clearance?

IVT INTRODUCER SHEATH received FDA 510(k) clearance on 1991-01-03, under 510(k) number K903463.

Who is the listed applicant for IVT INTRODUCER SHEATH?

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

What is the FDA product code for IVT INTRODUCER SHEATH?

The FDA product code for IVT INTRODUCER SHEATH 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 Intensive Technology, 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.

K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEMK912664TEC ROTATING DUAL HEMOVALVEK911869IVT GUIDING CATHETERK904003HEMOCHRON(R) HEPARIN RESPONSE TESTK901767MODIFIED IVT PERIPHERAL ATHERECTOMYK896403MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

View all 12 devices →

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

View on FDA Database →

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

↑