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FDA 510(k)

KIDNEY TRANSPLANT CATHETER

K-Number: K840687 · 1984-06-07

ApplicantWarne Surgical Products, Ltd.
Decision Date1984-06-07
Product CodeKDN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KIDNEY TRANSPLANT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Warne Surgical Products, Ltd.. It received FDA 510(k) clearance on 1984-06-07 under 510(k) number K840687. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIDNEY TRANSPLANT CATHETER?

KIDNEY TRANSPLANT CATHETER is a medical device that received FDA 510(k) clearance on 1984-06-07. The listed applicant is Warne Surgical Products, Ltd.. The 510(k) number is K840687.

When did KIDNEY TRANSPLANT CATHETER receive FDA 510(k) clearance?

KIDNEY TRANSPLANT CATHETER received FDA 510(k) clearance on 1984-06-07, under 510(k) number K840687.

Who is the listed applicant for KIDNEY TRANSPLANT CATHETER?

The FDA 510(k) record lists Warne Surgical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIDNEY TRANSPLANT CATHETER?

The FDA product code for KIDNEY TRANSPLANT CATHETER is KDN.

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Other records listing Warne Surgical Products, Ltd. 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.

K850694WSP CODE 4310 STRESSCATHK850696WSP CODE 4300 DIOMASTER DIAGNOSTICK850695WSP CODE 4301 DIOMASTER THERAPEUTICK850693WSP CODE 4315 PADTESTK841511HAEMATURIA CATHETERSK841410BUSH NECK W/TAP

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Related Devices (Code: KDN)

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.

K261644Perfadex PlusXvivo Perfusion ABK260456VI°Port™ Liver Preservation SystemTraferox Technologies, Inc.K254305BAROguard Donor Lung Preservation SystemParagonix Technologies, Inc.K243618EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)Bridge TO LifeK243870X°Port Lung Preservation System; X°Port Lung Preservation SolutionTraferox Technologies, Inc.K243998DCX Disposable Cassette (DCX)Institut Geroges Lopez

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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