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FDA 510(k)

STERILE URETHRAL CATHETER KIT

K-Number: K760897 · 1978-08-31

ApplicantDiamed Division Ill. Tool Works, Inc.
Decision Date1978-08-31
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STERILE URETHRAL 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 1978-08-31 under 510(k) number K760897. 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 STERILE URETHRAL CATHETER KIT?

STERILE URETHRAL CATHETER KIT is a medical device that received FDA 510(k) clearance on 1978-08-31. The listed applicant is Diamed Division Ill. Tool Works, Inc.. The 510(k) number is K760897.

When did STERILE URETHRAL CATHETER KIT receive FDA 510(k) clearance?

STERILE URETHRAL CATHETER KIT received FDA 510(k) clearance on 1978-08-31, under 510(k) number K760897.

Who is the listed applicant for STERILE URETHRAL 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 STERILE URETHRAL CATHETER KIT?

The FDA product code for STERILE URETHRAL CATHETER KIT is KOD.

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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-CATHK790728TOUCHLESS TM FOLEY 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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