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FDA 510(k)

CATH-TECH POLYURETHANE UMBILICAL VESS

K-Number: K842577 · 1985-03-13

ApplicantCatheter Technology Corp.
Decision Date1985-03-13
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CATH-TECH POLYURETHANE UMBILICAL VESS is the device name listed in this FDA 510(k) record. The listed applicant is Catheter Technology Corp.. It received FDA 510(k) clearance on 1985-03-13 under 510(k) number K842577. 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 CATH-TECH POLYURETHANE UMBILICAL VESS?

CATH-TECH POLYURETHANE UMBILICAL VESS is a medical device that received FDA 510(k) clearance on 1985-03-13. The listed applicant is Catheter Technology Corp.. The 510(k) number is K842577.

When did CATH-TECH POLYURETHANE UMBILICAL VESS receive FDA 510(k) clearance?

CATH-TECH POLYURETHANE UMBILICAL VESS received FDA 510(k) clearance on 1985-03-13, under 510(k) number K842577.

Who is the listed applicant for CATH-TECH POLYURETHANE UMBILICAL VESS?

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

What is the FDA product code for CATH-TECH POLYURETHANE UMBILICAL VESS?

The FDA product code for CATH-TECH POLYURETHANE UMBILICAL VESS is FOZ.

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Other records listing Catheter Technology Corp. 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.

K880571CATH-TECH PORT IMPLANTABLE VASCULAR ACCESS SYSTEMK871080PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERK871998GROSHONG CV CATHETER REPAIR KITK860256BRAWN AND GROSHONG CATHETERSK842147CATH-TECH CHOLANGIOGRAPHY CATHETERK840339UMBILICAL VESSEL 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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