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FDA 510(k)

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET

K-Number: K891406 · 1989-04-07

ApplicantCook Urological, Inc.
Decision Date1989-04-07
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET 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 1989-04-07 under 510(k) number K891406. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET?

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET is a medical device that received FDA 510(k) clearance on 1989-04-07. The listed applicant is Cook Urological, Inc.. The 510(k) number is K891406.

When did BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET receive FDA 510(k) clearance?

BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET received FDA 510(k) clearance on 1989-04-07, under 510(k) number K891406.

Who is the listed applicant for BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET?

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 BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET?

The FDA product code for BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET is LJE.

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Other records listing Cook Urological, 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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLE

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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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