THE AMPLATZ THROMBECTOMY DEVICE (ATD) MANUFACTURED BY EV3 INC.

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THE AMPLATZ THROMBECTOMY DEVICE (ATD)

Request for Information Form	Contact Information
Company Name	EV3 INC.
Address	4600 NATHAN LN. NORTH
City, State, Zip	PLYMOUTH, MN 55442
Country	US
FDA Owner/Operator Phone	763-398-7000
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	MCW
FDA Classification Name	CATHETER, PERIPHERAL, ATHERECTOMY
FDA Device Classification Code	Standards
FDA Regulation Number	870.4875
FDA Common Generic Name	THROMBECTOMY CATHETER
FDA Proprietary Device Name	THE AMPLATZ THROMBECTOMY DEVICE (ATD)
FDA Owner / Operator Number	9025796
FDA Owner / Operator Name	EV3 INC.
FDA Establishment Registration Number	2183870
FDA Registered Establishment Name	EV3 INC.
FDA Operation Code(s)	MM - Manufacturer MR - Remanufacturer MS - Specification Developer RR - Repackager/Relabeller
FDA Listing Date	04-29-05
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of EV3 INC.

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 VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	MULTIPLE	PERIPHERAL ATHERECTOMY CATHETER
2	BACCHUS VASCULAR, INC. 3110 CORONADO DR. SANTA CLARA, CA 95054 US 408-980-8300 / 408-980-8300 220	SOLERA BACCHUS THROMBECTOMY CATHETER	PERIPHERAL ATHERECTOMY CATHETER
3	BOSTON SCIENTIFIC CORK LTD. MODEL FARM RD. CORK, EI 508-652-5594 / 508-652-5594	ROTATIONAL ANGIOPLASTY SYSTEM (FOR USE IN PERIPHERAL ARTERIES)	ROTATIONAL ANGIOPLASTY SYSTEM (FOR USE IN PERIPHERAL ARTERIES)
4	BOSTON SCIENTIFIC CORPORATION 8600 N.W. 41ST STREET MIAMI, FL 33166 US 508-652-5594 / 508-652-5594	ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRE	ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES
5	CARDIOVASCULAR SYSTEMS INCORPORATED 651 CAMPUS DR. SAINT PAUL, MN 55112 US 651-259-1600 / 651-259-1600	ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT FOR A-V SHUNT	PERIPHERAL ATHERECTOMY
6	EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO, PR 00610 US 949-250-2500 / 949-250-2698	CATHETER, PERIPHERAL, ATHERECTOMY	PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT)
7	EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698	CATHETER, PERIPHERAL, ATHERECTOMY	PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT)
8	EV3 CORPORATION 9401 73RD AVE, NORTH SUITE 300 BROOKLYN PARK, MN 55428 US 763-398-7000 / 763-397-7546	THE AMPLATZ THROMBECTOMY DEVICE (ATD)	THROMBECTOMY CATHETER
9	EV3 NEUROVASCULAR 9775 TOLEDO WAY IRVINE, CA 92618 US 949-837-3700 1237 / 949-680-1237	THROMBOLYTIC BRUSH CATHETER AND MOTOR DRIVE	THROMBOLYTIC BRUSH CATHETER
10	FOX HOLLOW TECHNOLOGIES 740 BAY ROAD REDWOOD CITY, CA 94063 US 650-421-8400 / 650-839-8118	SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM	CATHETER,PERIPHERAL,ATHERECTOMY
11	IDEV TECHNOLOGIES, INC. 1120 NASA PARKWAY, STE. 600 HOUSTON, TX 77058 US 281-333-1998 / 281-333-1998 222	AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE	ELIMINATOR
12	INTERVENTIONAL PRODUCTS DIVISION 1300 MACARTHUR BLVD. MAHWAH, NJ 07430 US 201-391-8100 / 201-995-8758	CLEANER, ROTATIONAL THROMBECTOMY SYSTEM, VARIOUS NAMES	INTRALUMINAL ARTERY STRIPPER
13	KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE EXTON, PA 19341 US 484-713-2100 / 484-713-2146	THROMCAT THROMBECTOMY CATHETER SYSTEM	THROMBECTOMY CATHETER
14	NEOVASCULAR TECHNOLOGIES 2502 AVE."I" BROOKLYN, NY 11210 US 718-258-3004 / 718-258-3004	GELBFISH ENDOVAC SYSTEM	ENDOVASCULAR SUCTION CATHETER
15	POSSIS MEDICAL, INC. 9055 EVERGREEN BLVD., N.W. MINNEAPOLIS, MN 55433 US 763-780-4555 / 763-780-4555	ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM	ANGIOJET SYSTEM