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)

INTROSYTE CATHETER

K-Number: K974764 · 1998-02-26

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date1998-02-26
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INTROSYTE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. It received FDA 510(k) clearance on 1998-02-26 under 510(k) number K974764. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTROSYTE CATHETER?

INTROSYTE CATHETER is a medical device that received FDA 510(k) clearance on 1998-02-26. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K974764.

When did INTROSYTE CATHETER receive FDA 510(k) clearance?

INTROSYTE CATHETER received FDA 510(k) clearance on 1998-02-26, under 510(k) number K974764.

Who is the listed applicant for INTROSYTE CATHETER?

The FDA 510(k) record lists Becton Dickinson Infusion Therapy Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTROSYTE CATHETER?

The FDA product code for INTROSYTE CATHETER is FOZ.

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 Becton Dickinson Infusion Therapy 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.

K252137BD Insyte™ IV CatheterK251422BD Saf-T-Intima™ Subcutaneous Catheter SystemK243403BD Nexiva™ Closed IV Catheter SystemK251155BD Cathena™ Safety IV CatheterK251654BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV CatheterK250682BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector

View all 34 devices →

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

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.

↑