FDA 510(k)

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

K-Number: K183051 · 2019-07-16

Decision Date2019-07-16

Product CodeLJE

DecisionUnknown

Device Summary

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K183051. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Cook Incorporated. The 510(k) number is K183051.

When did Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set receive FDA 510(k) clearance?

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set received FDA 510(k) clearance on 2019-07-16, under 510(k) number K183051.

Who is the listed applicant for Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

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

What is the FDA product code for Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

The FDA product code for Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is LJE.

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Related Devices (Code: LJE)

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 Incorporated K190903Lawson 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.