Cope Nephroureterostomy Stent And Amplatz Ureteral Stent Set

Stent, Ureteral

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cope Nephroureterostomy Stent And Amplatz Ureteral Stent Set.

Pre-market Notification Details

• Device ID: K171603
• 510k Number: K171603
• Device Name: Cope Nephroureterostomy Stent And Amplatz Ureteral Stent Set
• Classification: Stent, Ureteral
• Applicant: Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Contact: Erum B. Nasir
• Correspondent: Erum B. Nasir; Cook Incorporated 750 Daniels Way Bloomington, IN 47402
• Product Code: FAD
• CFR Regulation Number: 876.4620 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-06-01
• Decision Date: 2018-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00827002481831	K171603	000
00827002481664	K171603	000
00827002481657	K171603	000
00827002481640	K171603	000
00827002481633	K171603	000
00827002481626	K171603	000
00827002481619	K171603	000
00827002481602	K171603	000
00827002481596	K171603	000
00827002300606	K171603	000
00827002481671	K171603	000
00827002481688	K171603	000
00827002481824	K171603	000
00827002481800	K171603	000
00827002481794	K171603	000
00827002481763	K171603	000
00827002481756	K171603	000
00827002481732	K171603	000
00827002481725	K171603	000
00827002481718	K171603	000
00827002481701	K171603	000
00827002117013	K171603	000