RX ACCUNET EMBOLIC PROTECTION DEVICE MANUFACTURED BY ABBOTT VASCULAR-VASCULAR SOLUTIONS

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Request for Information Form	Contact Information
Company Name	ABBOTT VASCULAR-VASCULAR SOLUTIONS
Address	3200 LAKESIDE DR.
City, State, Zip	SANTA CLARA, CA 95054
Country	US
FDA Owner/Operator Phone	847-937-6100
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	NTE
FDA Classification Name	CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
FDA Device Classification Code	Standards
FDA Regulation Number	870.1250
FDA Common Generic Name	EMBOLIC PROTECTION DEVICE
FDA Proprietary Device Name	RX ACCUNET EMBOLIC PROTECTION DEVICE
FDA Owner / Operator Number	1415939
FDA Owner / Operator Name	ABBOTT LABORATORIES
FDA Establishment Registration Number	3004635528
FDA Registered Establishment Name	ABBOTT VASCULAR-VASCULAR SOLUTIONS
FDA Operation Code(s)	MS - Specification Developer
FDA Listing Date	07-24-06
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	ABBOTT IRELAND VASCULAR DIVISION MERVUE BUSINESS PARK GALWAY, EI 847-937-6100 / 847-938-3471	EMBOSHIELD EMBOLIC PROTECTION SYSTEM	EMBOSHIELD EMBOLIC PROTECTION SYSTEM
2	ABBOTT VASCULAR-VASCULAR SOLUTIONS 26531 YNEZ RD. TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	RX ACCUNET EMBOLIC PROTECTION DEVICE	EMBOLIC PROTECTION DEVICE
3	BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. MOUNTAIN VIEW, CA 94043 US 508-652-5594 / 508-652-5594	EMBOLIC PROTECTION SYSTEMS AND ACCESSORIES	EMBOLIC PROTECTION GUIDEWIRE
4	CORDIS CORPORATION 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 US 786-313-2000 / 908-412-3065	ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE	STERILE, EMBOLI CAPTURE GUIDEWIRE
5	EV3 INC. 4600 NATHAN LN. NORTH PLYMOUTH, MN 55442 US 763-398-7000 / 763-398-7546	SPIDERX EMBOLIC PROTECTION DEVICE	EMBOLIC PROTECTION DEVICE
6	LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 PLYMOUTH, MN 55447 US 763-577-9600 / 763-746-9551	FIBERNET EMBOLI PROTECTION DEVICE SYSTEM	PERCUTANEOUS CATHETER