EVERCROSS 0.035 OTW PTA DILATATION CATHETER

Catheter, Angioplasty, Peripheral, Transluminal

EV3 INC

The following data is part of a premarket notification filed by Ev3 Inc with the FDA for Evercross 0.035 Otw Pta Dilatation Catheter.

Pre-market Notification Details

• Device ID: K110319
• 510k Number: K110319
• Device Name: EVERCROSS 0.035 OTW PTA DILATATION CATHETER
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: EV3 INC 3033 Campus Drive Plymouth, MN 55441
• Contact: Paula Cordero
• Correspondent: Paula Cordero; EV3 INC 3033 Campus Drive Plymouth, MN 55441
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-02-03
• Decision Date: 2011-04-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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