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FDA 510(k)

DISPOSABLE URODYNAMIC CATHETER SET

K-Number: K896784 · 1990-02-16

ApplicantLife-Tech Intl., Inc.
Decision Date1990-02-16
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE URODYNAMIC CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896784. 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 DISPOSABLE URODYNAMIC CATHETER SET?

DISPOSABLE URODYNAMIC CATHETER SET is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K896784.

When did DISPOSABLE URODYNAMIC CATHETER SET receive FDA 510(k) clearance?

DISPOSABLE URODYNAMIC CATHETER SET received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896784.

Who is the listed applicant for DISPOSABLE URODYNAMIC CATHETER SET?

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

What is the FDA product code for DISPOSABLE URODYNAMIC CATHETER SET?

The FDA product code for DISPOSABLE URODYNAMIC CATHETER SET is KOD.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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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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