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FDA 510(k)

PERCUFIX CATHETER CUFF

K-Number: K842890 · 1984-09-04

ApplicantMedi-Tech, Inc.
Decision Date1984-09-04
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUFIX CATHETER CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Tech, Inc.. It received FDA 510(k) clearance on 1984-09-04 under 510(k) number K842890. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUFIX CATHETER CUFF?

PERCUFIX CATHETER CUFF is a medical device that received FDA 510(k) clearance on 1984-09-04. The listed applicant is Medi-Tech, Inc.. The 510(k) number is K842890.

When did PERCUFIX CATHETER CUFF receive FDA 510(k) clearance?

PERCUFIX CATHETER CUFF received FDA 510(k) clearance on 1984-09-04, under 510(k) number K842890.

Who is the listed applicant for PERCUFIX CATHETER CUFF?

The FDA 510(k) record lists Medi-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERCUFIX CATHETER CUFF?

The FDA product code for PERCUFIX CATHETER CUFF is KOD.

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Other records listing Medi-Tech, Inc. as applicant

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K954457MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETERK952345MEDI-TECH PLATFORM GUIDE CATHETERK952056IMMUNOASSAY DRUGS OF ABUSE CONTROLSK945289DOA - IMMUNOASSAY CUT-OFF CALIBRATORK942551THERAPEUTIC DRUG MONITORING CONTROL, ASSAYEDK943290BILIRUBIN PLUS/PEDIATRIC CONTROLS

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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