FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM MANUFACTURED BY ACCELLENT INC.

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Request for Information Form	Contact Information
Company Name	ACCELLENT INC.
Address	1526-6 CALLE HERTZ
City, State, Zip	JUAREZ, CHIHUAHUA,
Country	MX
FDA Owner/Operator Phone	866-899-1392
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	NFA
FDA Classification Name	DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTECTION
FDA Device Classification Code	Standards
FDA Regulation Number	870.1250
FDA Common Generic Name	PERCUTANEOUS CATHETER
FDA Proprietary Device Name	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM
FDA Owner / Operator Number	9048369
FDA Owner / Operator Name	ACCELLENT INC.
FDA Establishment Registration Number	9680001
FDA Registered Establishment Name	ACCELLENT INC.
FDA Operation Code(s)	ME - Contract Manufacturer MM - Manufacturer MS - Specification Developer
FDA Listing Date	01-24-06
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. MOUNTAIN VIEW, CA 94043 US 508-652-5594 / 508-652-5594	MULTIPLE	VARIOUS TYPES OF EMBOLIC PROTECTION DEVICES
2	EV3 INC. 4600 NATHAN LN. NORTH PLYMOUTH, MN 55442 US 763-398-7000 / 763-398-7546	SPIDERX EMBOLIC PROTECTION DEVICE	EMBOLIC PROTECTION DEVICE
3	KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE EXTON, PA 19341 US 484-713-2100 / 484-713-2146	TRIACTIV SYSTEM	EMBOLIC PROTECTION DEVICE
4	LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 PLYMOUTH, MN 55447 US 763-577-9600 / 763-746-9551	FIBERNET EMBOLI CAPTURE SYSTEM	PERCUTANEOUS CATHETER
5	MEDTRONIC VASCULAR 35-37A CHERRY HILL DR DANVERS, MA 01923 US 763-514-4000 / 978-777-0042	GUARDWIRE PLUS	DISTAL PROTECTION SYSTEM
6	ST. JUDE MEDICAL 6550 WEDGWOOD RD. NORTH SUITE 150 MAPLE GROVE, MN 55311 US 651-483-2000 / 763-383-2639	PROXIS EMBOLIC PROTECTION SYSTEM, PROXIS FLOW CONTROL SYSTEM	EMBOLIC PROTECTION SYSTEM, FLOW CONTROL SYSTEM