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FDA 510(k)

OPTICALLY CLEAR RADIOPAQUE CATHETER

K-Number: K893546 · 1989-11-01

ApplicantCritikon Company, LLC
Decision Date1989-11-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPTICALLY CLEAR RADIOPAQUE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1989-11-01 under 510(k) number K893546. 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 OPTICALLY CLEAR RADIOPAQUE CATHETER?

OPTICALLY CLEAR RADIOPAQUE CATHETER is a medical device that received FDA 510(k) clearance on 1989-11-01. The listed applicant is Critikon Company, LLC. The 510(k) number is K893546.

When did OPTICALLY CLEAR RADIOPAQUE CATHETER receive FDA 510(k) clearance?

OPTICALLY CLEAR RADIOPAQUE CATHETER received FDA 510(k) clearance on 1989-11-01, under 510(k) number K893546.

Who is the listed applicant for OPTICALLY CLEAR RADIOPAQUE CATHETER?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTICALLY CLEAR RADIOPAQUE CATHETER?

The FDA product code for OPTICALLY CLEAR RADIOPAQUE CATHETER is FOZ.

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Other records listing Critikon Company, LLC 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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