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FDA 510(k)

TOUCHLESS TM FOLEY CATHETER KIT

K-Number: K790728 · 1979-06-01

ApplicantDiamed Division Ill. Tool Works, Inc.
Decision Date1979-06-01
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TOUCHLESS TM FOLEY CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diamed Division Ill. Tool Works, Inc.. It received FDA 510(k) clearance on 1979-06-01 under 510(k) number K790728. 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 TOUCHLESS TM FOLEY CATHETER KIT?

TOUCHLESS TM FOLEY CATHETER KIT is a medical device that received FDA 510(k) clearance on 1979-06-01. The listed applicant is Diamed Division Ill. Tool Works, Inc.. The 510(k) number is K790728.

When did TOUCHLESS TM FOLEY CATHETER KIT receive FDA 510(k) clearance?

TOUCHLESS TM FOLEY CATHETER KIT received FDA 510(k) clearance on 1979-06-01, under 510(k) number K790728.

Who is the listed applicant for TOUCHLESS TM FOLEY CATHETER KIT?

The FDA 510(k) record lists Diamed Division Ill. Tool Works, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOUCHLESS TM FOLEY CATHETER KIT?

The FDA product code for TOUCHLESS TM FOLEY CATHETER KIT is KOD.

Related Clinical Trials

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.

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Other records listing Diamed Division Ill. Tool Works, Inc. 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.

K854953DIAMED MODELS 600, 900, 960, 964K823450FEMALE EXTERNAL URINARY APPLIANCEK812281TOUCHLESS HOME-CATHK802664URINARY DRAINAGE UNTK802665TOUCHLESS CLEAN-CATHK760897STERILE URETHRAL CATHETER KIT

View all 7 devices →

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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