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FDA 510(k)

CARE + PLUS IRREGATION TRAY

K-Number: K863281 · 1986-10-31

ApplicantWelmed Systems, Inc.
Decision Date1986-10-31
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CARE + PLUS IRREGATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Welmed Systems, Inc.. It received FDA 510(k) clearance on 1986-10-31 under 510(k) number K863281. 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 CARE + PLUS IRREGATION TRAY?

CARE + PLUS IRREGATION TRAY is a medical device that received FDA 510(k) clearance on 1986-10-31. The listed applicant is Welmed Systems, Inc.. The 510(k) number is K863281.

When did CARE + PLUS IRREGATION TRAY receive FDA 510(k) clearance?

CARE + PLUS IRREGATION TRAY received FDA 510(k) clearance on 1986-10-31, under 510(k) number K863281.

Who is the listed applicant for CARE + PLUS IRREGATION TRAY?

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

What is the FDA product code for CARE + PLUS IRREGATION TRAY?

The FDA product code for CARE + PLUS IRREGATION TRAY 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 Welmed Systems, 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.

K863282CARE + PLUS CATHETER CARE TRAYK863497SUCTION CATHETER KITK863284I.V. START KITK863283CARE + PLUS SUTURE REMOVAL TRAYK862663TRACHEOSTOMY CARE TRAYK862219T.P.N. DRESSING CHANGE TRAY

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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