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FDA 510(k)

INSYTE CATHETER, INSYTE AUTOGUARD CATHETER

K-Number: K000235 · 2000-04-05

ApplicantBecton Dickinson Infusion Therapy Systems, Inc.
Decision Date2000-04-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSYTE CATHETER, INSYTE AUTOGUARD 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 2000-04-05 under 510(k) number K000235. 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 INSYTE CATHETER, INSYTE AUTOGUARD CATHETER?

INSYTE CATHETER, INSYTE AUTOGUARD CATHETER is a medical device that received FDA 510(k) clearance on 2000-04-05. The listed applicant is Becton Dickinson Infusion Therapy Systems, Inc.. The 510(k) number is K000235.

When did INSYTE CATHETER, INSYTE AUTOGUARD CATHETER receive FDA 510(k) clearance?

INSYTE CATHETER, INSYTE AUTOGUARD CATHETER received FDA 510(k) clearance on 2000-04-05, under 510(k) number K000235.

Who is the listed applicant for INSYTE CATHETER, INSYTE AUTOGUARD 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 INSYTE CATHETER, INSYTE AUTOGUARD CATHETER?

The FDA product code for INSYTE CATHETER, INSYTE AUTOGUARD CATHETER is FOZ.

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Other records listing Becton Dickinson Infusion Therapy Systems, Inc. as applicant

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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.

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