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FDA 510(k)

INSYTE INTRODUCER CATHETER

K-Number: K942045 · 1995-01-09

ApplicantBecton Dickinson Vascular Access, Inc.
Decision Date1995-01-09
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSYTE INTRODUCER CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Becton Dickinson Vascular Access, Inc.. It received FDA 510(k) clearance on 1995-01-09 under 510(k) number K942045. 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 INTRODUCER CATHETER?

INSYTE INTRODUCER CATHETER is a medical device that received FDA 510(k) clearance on 1995-01-09. The listed applicant is Becton Dickinson Vascular Access, Inc.. The 510(k) number is K942045.

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

INSYTE INTRODUCER CATHETER received FDA 510(k) clearance on 1995-01-09, under 510(k) number K942045.

Who is the listed applicant for INSYTE INTRODUCER CATHETER?

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

What is the FDA product code for INSYTE INTRODUCER CATHETER?

The FDA product code for INSYTE INTRODUCER CATHETER is FOZ.

Related Clinical Trials

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Other records listing Becton Dickinson Vascular Access, 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.

K971339INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERSK970259E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SETK964049FIRST MIDCATH CATHETER WITH DUAL LUMENSK964050FIRST MIDCATH CATHETERK964048FIRST MIDCATH CATHETER KITK954906FIRST PICC INTRODUCER CATHETER

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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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