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FDA 510(k)

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set

K-Number: K183051 · 2019-07-16

ApplicantCook Incorporated
Decision Date2019-07-16
Product CodeLJE
DecisionUnknown

Device Summary

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2019-07-16 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K183051.

When was Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set approved by the FDA?

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

What company makes Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set?

Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set is manufactured by Cook Incorporated.

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.

Related Clinical Trials

NCT06872905 Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease RECRUITING NCT06394739 RevCore for In Stent Thrombosis RECRUITING NCT06353594 Reduced Stent Strategy Versus Conventional Percutaneous Coronary Revascularization in Patients Presenting With STEMI RECRUITING NCT05846893 Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease ACTIVE_NOT_RECRUITING NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN NCT04647253 A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) ACTIVE_NOT_RECRUITING

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Related Devices (Code: LJE)

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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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