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FDA 510(k)

Ultraxx Nephrostomy Balloon Catheter Set

K-Number: K181713 · 2018-08-17

ApplicantCook Incorporated
Decision Date2018-08-17
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Ultraxx Nephrostomy Balloon Catheter 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 2018-08-17 under 510(k) number K181713. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraxx Nephrostomy Balloon Catheter Set?

Ultraxx Nephrostomy Balloon Catheter Set is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Cook Incorporated. The 510(k) number is K181713.

When did Ultraxx Nephrostomy Balloon Catheter Set receive FDA 510(k) clearance?

Ultraxx Nephrostomy Balloon Catheter Set received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181713.

Who is the listed applicant for Ultraxx Nephrostomy Balloon Catheter 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 Ultraxx Nephrostomy Balloon Catheter Set?

The FDA product code for Ultraxx Nephrostomy Balloon Catheter Set is LJE.

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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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