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FDA 510(k)

CATHETER METAL HUB/RADIOPAQUE

K-Number: K790967 · 1979-06-27

ApplicantJelco Laboratories
Decision Date1979-06-27
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CATHETER METAL HUB/RADIOPAQUE is the device name listed in this FDA 510(k) record. The listed applicant is Jelco Laboratories. It received FDA 510(k) clearance on 1979-06-27 under 510(k) number K790967. 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 CATHETER METAL HUB/RADIOPAQUE?

CATHETER METAL HUB/RADIOPAQUE is a medical device that received FDA 510(k) clearance on 1979-06-27. The listed applicant is Jelco Laboratories. The 510(k) number is K790967.

When did CATHETER METAL HUB/RADIOPAQUE receive FDA 510(k) clearance?

CATHETER METAL HUB/RADIOPAQUE received FDA 510(k) clearance on 1979-06-27, under 510(k) number K790967.

Who is the listed applicant for CATHETER METAL HUB/RADIOPAQUE?

The FDA 510(k) record lists Jelco Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER METAL HUB/RADIOPAQUE?

The FDA product code for CATHETER METAL HUB/RADIOPAQUE is FOZ.

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Other records listing Jelco Laboratories 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.

K791918JELCO WINGED INTRAVASCULAR CATHETERK791372JELCO & KVO CATHETER PLACEMENT UNITK790968CATHETER METAL HUB/NONRADIOPAQUEK790471JELCO* DISC FILTER-0.2 MICRONK790186PROTECTIVSTABILIZERK790079NEEDLE, BLOOD COLLECTING

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Related Devices (Code: FOZ)

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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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