Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

K-Number: K211911 · 2022-03-10

ApplicantColoplast Corp.
Decision Date2022-03-10
Product CodeLJE
DecisionUnknown

Device Summary

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is a medical device manufactured by Coloplast Corp.. It received FDA 510(k) clearance on 2022-03-10 under approval number K211911. The device is classified under product code LJE. FDA Decision: Unknown.

Frequently Asked Questions

What is the Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Coloplast Corp.. The 510(k) number is K211911.

When was Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets approved by the FDA?

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets received FDA 510(k) clearance on 2022-03-10, under approval number K211911.

What company makes Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is manufactured by Coloplast Corp..

What is the FDA product code for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets?

The FDA product code for Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets is LJE.

Related Clinical Trials

NCT07595835 CT-guided Percutaneous Radionuclide Therapy With 32P Microparticles in Patients With Non-progressive Locally Advanced Pancreatic Cancer RECRUITING NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT07063381 Low-frequency Electrical Stimulation for Cognitive Enhancement in Atrial Fibrillation ENROLLING_BY_INVITATION NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING NCT07535593 Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness NOT_YET_RECRUITING

Other Devices by Coloplast Corp.

K161672SpeediCath Flex Coude K171043Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters K170362VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS K170422BIOSOFT DUO DOUBLE LOOP URETERAL STENTS K170531Ureteral Dilators and Percutaneous Nephrostomy Dilators K182831SabreLine and SabreGuard Laser Fibers

View all 27 devices →

Related Devices (Code: LJE)

K160077RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture SetJbw7 Innovations, LLC K172527Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque StripeCook Incorporated K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated K171601Ultraxx Nephrostomy Balloon CatheterCook Incorporated K172929Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal SheathBoston Scientific Corporation 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.

↑