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FDA 510(k)

CATH-TECH CHOLANGIOGRAPHY CATHETER

K-Number: K842147 · 1984-10-02

ApplicantCatheter Technology Corp.
Decision Date1984-10-02
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATH-TECH CHOLANGIOGRAPHY CATHETER 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 1984-10-02 under 510(k) number K842147. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATH-TECH CHOLANGIOGRAPHY CATHETER?

CATH-TECH CHOLANGIOGRAPHY CATHETER is a medical device that received FDA 510(k) clearance on 1984-10-02. The listed applicant is Catheter Technology Corp.. The 510(k) number is K842147.

When did CATH-TECH CHOLANGIOGRAPHY CATHETER receive FDA 510(k) clearance?

CATH-TECH CHOLANGIOGRAPHY CATHETER received FDA 510(k) clearance on 1984-10-02, under 510(k) number K842147.

Who is the listed applicant for CATH-TECH CHOLANGIOGRAPHY CATHETER?

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 CHOLANGIOGRAPHY CATHETER?

The FDA product code for CATH-TECH CHOLANGIOGRAPHY CATHETER is FGE.

Related Clinical Trials

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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 CATHETERSK842577CATH-TECH POLYURETHANE UMBILICAL VESSK840339UMBILICAL VESSEL CATHETER

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Related Devices (Code: FGE)

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.

K254179Drainage CatheterCanyon Medical, Inc.K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019Hangzhou AGS MedTech Co., Ltd.K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ Biliary & Pancreatic Stent SetsMedi-Globe GmbH

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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