PROTEGE GPS SELF-EXPANDING NITINOL STENT

Stents, Drains And Dilators For The Biliary Ducts

EV3 CORPORATION

The following data is part of a premarket notification filed by Ev3 Corporation with the FDA for Protege Gps Self-expanding Nitinol Stent.

Pre-market Notification Details

• Device ID: K050725
• 510k Number: K050725
• Device Name: PROTEGE GPS SELF-EXPANDING NITINOL STENT
• Classification: Stents, Drains And Dilators For The Biliary Ducts
• Applicant: EV3 CORPORATION 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920
• Contact: Glen D Smythe
• Correspondent: Glen D Smythe; EV3 CORPORATION 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920
• Product Code: FGE
• CFR Regulation Number: 876.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-21
• Decision Date: 2005-04-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00821684071786	K050725	000
00821684031766	K050725	000
00821684031773	K050725	000
00821684031780	K050725	000
00821684031797	K050725	000
00821684031803	K050725	000
00821684031810	K050725	000
00821684031827	K050725	000
00821684031834	K050725	000
00821684031759	K050725	000
00821684031742	K050725	000
00821684031667	K050725	000
00821684031674	K050725	000
00821684031681	K050725	000
00821684031698	K050725	000
00821684031704	K050725	000
00821684031711	K050725	000
00821684031728	K050725	000
00821684031735	K050725	000
00821684031841	K050725	000
00821684071595	K050725	000
00821684071700	K050725	000
00821684071717	K050725	000
00821684071724	K050725	000
00821684071731	K050725	000
00821684071748	K050725	000
00821684071755	K050725	000
00821684071762	K050725	000
00821684071779	K050725	000
00821684071694	K050725	000
00821684071687	K050725	000
00821684071601	K050725	000
00821684071618	K050725	000
00821684071625	K050725	000
00821684071632	K050725	000
00821684071649	K050725	000
00821684071656	K050725	000
00821684071663	K050725	000
00821684071670	K050725	000
00821684031650	K050725	000