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FDA 510(k)

MALECOT-NEPHROSTOMY TAMPONADE CATHETER

K-Number: K915209 · 1992-11-10

ApplicantCook Urological, Inc.
Decision Date1992-11-10
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

MALECOT-NEPHROSTOMY TAMPONADE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 1992-11-10 under 510(k) number K915209. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALECOT-NEPHROSTOMY TAMPONADE CATHETER?

MALECOT-NEPHROSTOMY TAMPONADE CATHETER is a medical device that received FDA 510(k) clearance on 1992-11-10. The listed applicant is Cook Urological, Inc.. The 510(k) number is K915209.

When did MALECOT-NEPHROSTOMY TAMPONADE CATHETER receive FDA 510(k) clearance?

MALECOT-NEPHROSTOMY TAMPONADE CATHETER received FDA 510(k) clearance on 1992-11-10, under 510(k) number K915209.

Who is the listed applicant for MALECOT-NEPHROSTOMY TAMPONADE CATHETER?

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

What is the FDA product code for MALECOT-NEPHROSTOMY TAMPONADE CATHETER?

The FDA product code for MALECOT-NEPHROSTOMY TAMPONADE CATHETER is LJE.

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Other records listing Cook Urological, Inc. as applicant

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Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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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