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COOK FLOW DIRECTED BALLOON CATHETER
 Request for Information Form |
 Contact Information
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| 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 | DYG |
| FDA Classification Name | CATHETER, FLOW DIRECTED |
| FDA Device Classification Code | Standards |
| FDA Regulation Number | 870.1240 |
| FDA Common Generic Name | FLOW DIRECTED CATHETER |
| FDA Proprietary Device Name | COOK FLOW DIRECTED BALLOON 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 | 07-09-04 |
| 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 100 AND 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064 US 847-937-6100 / 847-938-3471 |
MULTIPLE | VARIOUS TYPES OF FLOW DIRECTED CATHETER |
| 2 | ALPHA MEDICAL INSTRUMENTS LLC 23455 MADERO SUITE B MISSION VIEJO, CA 92691 US 949-460-0944 / 949-460-0944 |
ALPHA THERMODILUTION CATHETERS | STERILE DIAGNOSTIC CATHETERS |
| 3 | AORTECH INTERNATIONAL PLC 81-83 VICTORIA ROAD PRESTIGE TRAVEL SUITE SURBITON, SURREY, KT6 4NS UK 44-208-3993961 / 44-169-8746699 |
TRUCATH | STERILE CONTINUOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER |
| 4 | ARGON MEDICAL DEVICES INC. 1445 FLAT CREEK RD. ATHENS, TX 75751 US 903-675-9321 / 903-677-9343 |
ARGON SEPTISHIELD-THERMODILUTION CATHETER-RELIEF VALVE | SEPTISHIELD THERMODILUTION CATHETER SAFEWEDGE RELIEF VALVE DEVICE |
| 5 | ARROW INTL., INC. 2 BERRY DR. MT. HOLLY, NJ 08060 US 610-378-0131 / 610-378-0131 |
BALLOON WEDGE TYPE CATHETER | |
| 6 | ARROW INTL., INC. 312 COMMERCE PL. ASHEBORO, NC 27203 US 610-378-0131 / 610-378-0131 |
BALLOON WEDGE PRESSURE CATHETERS | |
| 7 | B. BRAUN MEDICAL, INC. 1940 OLNEY AVE, STE 200 CHERRY HILL, NJ 08003 US 610-691-5400 / 610-596-2536 |
MULTIPLE | VARIOUS FLOW-DIRECTED CATHETERS |
| 8 | BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. 198 YISHUN AVE. 7 SINGAPORE, 768926 SN 201-847-6800 / 801-565-2550 |
CRITICATH THERMODILUTION CATHETERS | PULMONARY ARTERY CATHETER |
| 9 | BIOSENSE WEBSTER, INC. 5110 COMMERCE RD. BALDWIN PARK, CA 91706 US 909-839-8604 / 909-839-8998 |
CORONARY SINUS FLOW CATHETER | |
| 10 | BIOSENSORS INTL. PTE. LTD. 21 KALLANG AVENUE #04-175 SINGAPORE, 339412 SN 65-629-38066 / 65-629-38066 |
MULTIPLE | VARIOUS |
| 11 | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513 |
TRU-TRAC PTA BALLOON CATHETER | BALLOON CATHETER |
| 12 | C.R. BARD, INC. 289 BAY RD. QUEENSBURY, NY 12804 US 908-277-8000 / 908-277-8513 |
TRU-TRAC PTA BALLOON CATHETER | BALLOON CATHETER |
| 13 | CLINICAL INSTRUMENTS INTL., INC. 278 WORCESTER ST. SOUTHBRIDGE, MA 01550 US 508-764-2200 / 508-764-2200 |
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| 14 | CORDIS CORPORATION 14201 N.W. 60TH AVE. MIAMI LAKES, FL 33014 US 786-313-2000 / 908-412-3065 |
FLOW DIRECTED BALLOON CATHETER | CARDIOVASCULAR CATHETER |
| 15 | CORDIS EUROPA, N.V. OOSTEINDE 8 RODEN, NL-9301 LJ NL 786-313-2000 / 908-412-3065 |
FLOW DIRECTED BALLOON CATHETER | CARDIOVASCULAR CATHETER |
| 16 | EDWARDS LIFESCIENCES TECHNOLOGY SARL STATE RD. 402 N.KM 1.4 ANASCO, PR 00610 US 949-250-2500 / 949-250-2698 |
SWAN-GANZ CATHETER | VARIOUS |
| 17 | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698 |
SWAN-GANZ CATHETER | VARIOUS |
| 18 | HANTEL TECHNOLOGIES 721 SANDOVAL WAY HAYWARD, CA 94544 US 510-487-1561 17 / 510-487-1561 17 |
NONE | FLOW-DIRECTED CATHETER |
| 19 | HARMAC MEDICAL PRODUCTS, INC. 2201 BAILEY AVE. BUFFALO, NY 14211 US 716-897-4500 / 716-897-4500 189 |
MULTIPLE | VARIOUS STERILE CARDIAC THERMODILUTION CATHETERS |
| 20 | HOSPIRA HOLDINGS DE COSTA RICA LTD. ZONA FRANCA GLOBAL LA AURORA DE HEREDIA, CS 224-212-4517 / 224-212-4688 |
MULTIPLE | VARIOUS TYPES OF FLOW DIRECTED CATHETER |
| 21 | HOSPIRA LTD. CARRETERA SANCHEZ, KM 18 1/2 PARQUE INDUSTRIAL ITABO, S.A. HAINA, SAN CRISTOBAL, DR 224-212-4517 / 224-212-4688 |
MULTIPLE | VARIOUS TYPES OF FLOW DIRECTED CATHETERS |
| 22 | HOSPIRA,INC. 375 N. FIELD DR. LAKE FOREST, IL 60045 US 224-212-4517 / 224-212-4688 |
MULTIPLE | VARIOUS TYPES OF FLOW DIRECTED CATHETERS |
| 23 | ICU MEDICAL, INC 4455 ATHERTON DR. SALT LAKE CITY, UT 84123 US 949-366-2183 / 801-264-1384 |
MULTIPLE | VARIOUS TYPES OF FLOW DIRECTED CATHETER |
| 24 | LEMAITRE VASCULAR, INC. 63 2ND AVENUE BURLINGTON, MA 01803 US 781-221-2266 / 781-221-2266 105 |
PRUITT BALLOON OCCLUSION CATHETER | OCCLUSION CATHETER |
| 25 | MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT 7000 CENTRAL AVE. N.E. MINNEAPOLIS, MN 55432 US 763-514-4000 / 763-505-7831 |
MODEL 6215 ATTAIN VENOGRAM BALLOON CATHETER | VENOGRAM BALOON CATHETER |
| 26 | OMEGA CRITICAL CARE LIMITED OMEGA HOUSE, 2 CAIRN COURT NERSTON WEST EAST KILBRIDE, G74 4NB UK 44-135-5265733 / 44-135-5265733 |
TRUCATH AND TRUCATH.IP | STERILE CONTINUOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETERS |
| 27 | PROGRESSIVE ANGIOPLASTY SYSTEMS CANADA, INC. 11220 VOYAGEUR WAY, #1 RICHMOND, B.C., V6X 3EI CA / 516-379-8943 |
ACT-ONE, TNT & IMPAX-T | BALLOON CATHETER OR ANGIOPLASTY CATHETER |
| 28 | VITALCOR, INC. 100 EAST CHESTNUT AVE. WESTMONT, IL 60559 US 630-325-5500 / 630-325-5500 111 |
BALLOON TYPE CARDIOVASCULAR CATHETER | BALLOON TYPE CARDIOVASCULAR CATHETER |
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