BIOSOFT DUO DOUBLE LOOP URETERAL STENTS

Stent, Ureteral

Coloplast Corp

The following data is part of a premarket notification filed by Coloplast Corp with the FDA for Biosoft Duo Double Loop Ureteral Stents.

Pre-market Notification Details

• Device ID: K170422
• 510k Number: K170422
• Device Name: BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
• 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: 2017-02-13
• Decision Date: 2017-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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