Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set

Catheter, Nephrostomy

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set.

Pre-market Notification Details

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• Device ID: K181735
• 510k Number: K181735
• Device Name: Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
• Classification: Catheter, Nephrostomy
• Applicant: Cook Incorporated 750 Daniels Way Bloomington, IN 47404
• Contact: Paul Meyer
• Correspondent: Paul Meyer; Cook Incorporated 750 Daniels Way Bloomington, IN 47404
• Product Code: LJE
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-02
• Decision Date: 2019-03-27
• Summary: summary