MODIFICATION TO NITREX NITINOL GUIDEWIRE

Wire, Guide, Catheter

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Modification To Nitrex Nitinol Guidewire.

Pre-market Notification Details

• Device ID: K040345
• 510k Number: K040345
• Device Name: MODIFICATION TO NITREX NITINOL GUIDEWIRE
• Classification: Wire, Guide, Catheter
• Applicant: EV3 INC 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920
• Contact: Carolyn Anderson
• Correspondent: Carolyn Anderson; EV3 INC 4600 NATHAN LN. NORTH Plymouth, MN 55442 -2920
• Product Code: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-12
• Decision Date: 2004-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20763000185491	K040345	000
20763000185361	K040345	000
20763000185354	K040345	000
20763000185347	K040345	000
10821684001414	K040345	000
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20763000185408	K040345	000
10821684009236	K040345	000
10821684009229	K040345	000
10821684009083	K040345	000
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10821684009038	K040345	000
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10821684009151	K040345	000
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10821684009137	K040345	000
10821684009120	K040345	000
10821684001438	K040345	000
00821684058404	K040345	000
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00821684058312	K040345	000
00821684058183	K040345	000
00821684058176	K040345	000
20763000185590	K040345	000
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20763000185576	K040345	000
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00821684058107	K040345	000
20763000185644	K040345	000
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20763000185507	K040345	000