ACCENT DG BALLOON ANGIOPLASTY CATHETER MANUFACTURED BY COOK, INC.

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ACCENT DG BALLOON ANGIOPLASTY CATHETER

Request for Information Form	Contact Information
Company Name	COOK, INC.
Address	750 DANIELS WAY PO BX 489
City, State, Zip	BLOOMINGTON, IN 47402
Country	US
FDA Owner/Operator Phone	812-339-2235
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	LIT
FDA Classification Name	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
FDA Device Classification Code	Standards
FDA Regulation Number	870.1250
FDA Common Generic Name	BALLOON ANGIOPLASTY CATHETER
FDA Proprietary Device Name	ACCENT DG BALLOON ANGIOPLASTY CATHETER
FDA Owner / Operator Number	1820334
FDA Owner / Operator Name	COOK, INC.
FDA Establishment Registration Number	1820334
FDA Registered Establishment Name	COOK, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	04-07-04
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

Competitors of COOK, 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 LABORATORIES VASCULAR ENTERPRISES, LTD., DU ZWEIGNIEDERLASSUNG BERINGEN AMPTHAUPTSTRASSE, POSTAH BERINGEN, CH-8222 SZ 847-937-6100 / 847-938-3471	FOX PTA CATHETER PTA CATHETER	PTA CATHETER
2	ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	MULTIPLE	PERIPHERAL CATHETER
3	ABBOTT VASCULAR-CARDIAC THERAPIES 3200 LAKESIDE DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	MULTIPLE	PERIPHERAL CATHETER
4	ABBOTT VASCULAR-VASCULAR SOLUTIONS 26531 YNEZ RD. TEMECULA, CA 92589 US 847-937-6100 / 847-938-3471	AGILTRAC,RX VIATRAC	PERIPHERAL CATHETER
5	ABBOTT VASCULAR-VASCULAR SOLUTIONS 3200 LAKESIDE DR. SANTA CLARA, CA 95054 US 847-937-6100 / 847-938-3471	AGILTRAC, RX VIATRAC	PERIPHERAL CATHETER
6	ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. QUEENSBURY, NY 12804 US 518-798-1215 / 518-798-1215 123	MULTIPLE	BALLOON CATHETER
7	ANGIOSCORE, INC. 965 ATLANTIC AVE., SUITE 101 ALAMEDA, CA 94501 US 510-933-7900 / 510-933-7904	ANGIOSCULPT SCORING BALLOON CATHETER	CATHETER
8	ANGIOSCORE, INC. 5055 BRANDIN COURT FREMONT, CA 94538 US 510-933-7900 / 510-933-7904	ANGIOSCULPT SCORING BALLOON CATHETER	CATHETER
9	BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. P.O. BOX 1740 TEMPE, AZ 85280 US 908-277-8000 / 908-277-8513	MULTIPLE	BALLOON CATHETERS
10	BIOTRONIK AG ACKERSTRASSE 6 BULACH, CH-8180 SZ 49-30-689051200 / 411-864-5247	MULTIPLE	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY(PTA)CATHETER
11	BIPORE, INC. 31 INDUSTRIAL PKWY. NORTHVALE, NJ 07647 US 201-767-1993 / 201-767-1993	BIPORE BALLOON DILATATION CATHETER	BALLOON DILATATION CATHETER
12	BOLTON MEDICAL, INC. 799 INTERNATIONAL PARKWAY SUNRISE, FL 33325 US 954-838-9699 / 954-838-9699 251	MULTIPLE	PTA CATHETER
13	BOSTON SCIENTIFIC CORK LTD. MODEL FARM RD. CORK, EI 508-652-5594 / 508-652-5594	PEMT LARGE VESSEL BALLOON	VARIOUS TYPES OF BALLOON DILITATION CATHETERS
14	BOSTON SCIENTIFIC CORPORATION LISNENAN & THORN RD LETTERKENNY, COUNTY DONEGAL, EI 508-652-5594 / 508-652-5594	PERIPHERAL CUTTING BALLON	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)
15	BOSTON SCIENTIFIC CORPORATION 3574 RUFFIN RD SAN DIEGO, CA 92123 US 508-652-5594 / 508-652-5594	PERIPHERAL CUTTING BALLOON	PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)
16	BOSTON SCIENTIFIC CORPORATION 160 KNOWLES DRIVE LOS GATOS, CA 95032 US 508-652-5594 / 508-652-5594	CVS (TM) PERIPHERAL BALLOON CATHETER, POLARCATH(TM) BALLOON CATHETER	BALLON DILATATION CATHETER
17	BOSTON SCIENTIFIC CORPORATION, NAMIC TECHNOLOGY CT 10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY 12801 US 508-652-5594 / 508-652-5594	MULTIPLE	VARIOUS TYPES OF ANGIOPLASTY ACCESSORIES
18	BOSTON SCIENTIFIC IRELAND, LTD. BALLYBRIT BUSINESS PARK GALWAY, EI 508-652-5594 / 508-652-5594	BLUE MAX BALLOON DILATATION CATHETERS	BALLOON DILATATION CATHETER
19	BOSTON SCIENTIFIC TULLAMORE,LIMITED SRAGH INDUSTRIAL ESTATE TULLAMORE, COUNTY OFFALY, EI 508-652-5594 / 508-652-5594	VARIOUS TYPES OF ANGIOPLASTY ACCESSORIES	VARIOUS TYPES OF ANGIOPLASTY ACCESSORIES
20	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513	OPTI-PLAST, ULTRAVERSE, CENTURION, MULTIPLE	PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
21	C.R. BARD, INC. 289 BAY RD. QUEENSBURY, NY 12804 US 908-277-8000 / 908-277-8513	MULTIPLE	BALLOON CATHETERS
22	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513	OPTIPLAST PERIPHERAL & TRU-TRAC PTA BALLOONDILATATION CATHETER	PERCUTANEOUS CATHETERS
23	CORDIS CORPORATION 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 US 786-313-2000 / 908-412-3065	OPTA 5	STERILE PTA CATHETERS
24	CORDIS DE MEXICO, S.A. DE C.V. CIRCUITO INTERIOR NORTE #1820 PARQUE INDUSTRIAL SALVARCAR CD. JUAREZ, CHIHUAHUA, 32580 MX 786-313-2000 / 908-412-3065	MULTIPLE	STERILE PTCA CATHETER
25	CORDIS EUROPA, N.V. OOSTEINDE 8 RODEN, NL-9301 LJ NL 786-313-2000 / 908-412-3065	OPTA 5	PTA CATHETERS, STERILE
26	FFM MED REPS, LLC 3145 COPPER AVE. FENTON, MI 48430 US 810-714-4775 / 810-714-4775	EXCEL Y-CONNECTOR CAT.#E-201	VARIOUS TYPES OF STERILE AND NON-STERILE Y-CONNECTORS
27	INSITU TECHNOLOGIES, INC. 5810 BLACKSHIRE PATH INVER GROVE HEIGHTS, MN 55076 US 651-389-1017 / 651-389-1017	PERSEUS PTA BALLOON CATHETER	PTA BALLOON CATHETER
28	NORFOLK MEDICAL PRODUCTS, INC. 7350 NORTH RIDGEWAY SKOKIE, IL 60076 US 847-674-7075 / 847-674-7075	OMEGAPORT	CATHETERS
29	NUMED CANADA, INC. 45 SECOND ST. CORNWALL, ONTARIO, K6J 1G3 CA 613-936-2592 / 315-328-4491	MULTIPLE	VARIOUS TYPES OF CATHETERS
30	RADIUS MEDICAL TECHNOLOGIES, INC. 15 CRAIG ROAD ACTON, MA 01720 US 978-263-4466 / 978-263-4466	RADIUS PTCA GUIDEWIRE	GUIDEWIRE
31	THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. MALVERN, PA 19355 US 973-790-1330 / 610-296-3000	HEMOSTATIC WYE CONNECTOR	HEMOSTATIC WYE CONNECTOR