ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent

Stent, Ureteral

Coloplast Corp

The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Imajin Silicone Hydro-coated Double Loop Ureteral Stent.

Pre-market Notification Details

• Device ID: K180469
• 510k Number: K180469
• Device Name: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
• Classification: Stent, Ureteral
• Applicant: Coloplast Corp 1601 West River Road North Minneapolis, MN 55411
• Contact: Cori Ragan
• Correspondent: Cori Ragan; Coloplast Corp 1601 West River Road North Minneapolis, MN 55411
• Product Code: FAD
• CFR Regulation Number: 876.4620 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-21
• Decision Date: 2018-11-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05708932703048	K180469	000
05708932703901	K180469	000
05708932703871	K180469	000
05708932703840	K180469	000
05708932703819	K180469	000
05708932703789	K180469	000
05708932703734	K180469	000
05708932703703	K180469	000
05708932703673	K180469	000
05708932703932	K180469	000
05708932703963	K180469	000
05708932704205	K180469	000
05708932704175	K180469	000
05708932704144	K180469	000
05708932704113	K180469	000
05708932704083	K180469	000
05708932704052	K180469	000
05708932704021	K180469	000
05708932703994	K180469	000
05708932703642	K180469	000
05708932703611	K180469	000
05708932703284	K180469	000
05708932703253	K180469	000
05708932703222	K180469	000
05708932703192	K180469	000
05708932703161	K180469	000
05708932703130	K180469	000
05708932703109	K180469	000
05708932703079	K180469	000
05708932703314	K180469	000
05708932703345	K180469	000
05708932703581	K180469	000
05708932703550	K180469	000
05708932703529	K180469	000
05708932703499	K180469	000
05708932703468	K180469	000
05708932703437	K180469	000
05708932703406	K180469	000
05708932703376	K180469	000
05708932704236	K180469	000
05708932704267	K180469	000
05708932705103	K180469	000
05708932705073	K180469	000
05708932705042	K180469	000
05708932705011	K180469	000
05708932704984	K180469	000
05708932704953	K180469	000
05708932704922	K180469	000
05708932704892	K180469	000
05708932705134	K180469	000
05708932705165	K180469	000
05708932705400	K180469	000
05708932705370	K180469	000
05708932705349	K180469	000
05708932705318	K180469	000
05708932705288	K180469	000
05708932705257	K180469	000
05708932705226	K180469	000
05708932705196	K180469	000
05708932704861	K180469	000
05708932704830	K180469	000
05708932704502	K180469	000
05708932704472	K180469	000
05708932704441	K180469	000
05708932704410	K180469	000
05708932704380	K180469	000
05708932704359	K180469	000
05708932704328	K180469	000
05708932704298	K180469	000
05708932704533	K180469	000
05708932704564	K180469	000
05708932704809	K180469	000
05708932704779	K180469	000
05708932704748	K180469	000
05708932704717	K180469	000
05708932704687	K180469	000
05708932704656	K180469	000
05708932704625	K180469	000
05708932704595	K180469	000
05708932705431	K180469	000