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PROSTHETIC HEART VALVE SIZER
 Request for Information Form |
 Contact Information
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| Company Name | CARBOMEDICS, INC. |
| Address | 14401 WEST 65TH WAY |
| City, State, Zip | ARVADA, CO 80004 |
| Country | US |
| FDA Owner/Operator Phone | 512-435-3200 |
| FDA Medical Specialty Code | CV - Cardiovascular |
| FDA Product Code | DTI |
| FDA Classification Name | SIZER, HEART-VALVE, PROSTHESIS |
| FDA Device Classification Code | General Controls |
| FDA Regulation Number | 870.3945 |
| FDA Common Generic Name | VALVE SIZER |
| FDA Proprietary Device Name | PROSTHETIC HEART VALVE SIZER |
| FDA Owner / Operator Number | 9045019 |
| FDA Owner / Operator Name | CARBOMEDICS, INC. |
| FDA Establishment Registration Number | 3006429362 |
| FDA Registered Establishment Name | CARBOMEDICS, INC. |
| FDA Operation Code(s) |
MM - Manufacturer MR - Remanufacturer RR - Repackager/Relabeller |
| FDA Listing Date | 07-03-07 |
| FDA Listing Status Code | Active |
| Differentiation | N/A |
| Keywords | N/A |
| Description | N/A |
| Brochure | N/A |
| Product Website | N/A |
Competitors of CARBOMEDICS, 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 | 3F THERAPEUTICS, INC. 20412 JAMES BAY CIRCLE LAKE FOREST, CA 92630 US 949-380-9333 / 949-380-9333 235 |
SIZER, HEART-VALVE, PROSTHESIS | SIZER, HEART-VALVE, PROSTHESIS |
| 2 | CARBOMEDICS, INC. 1300 EAST ANDERSON LANE AUSTIN, TX 78752 US 512-435-3200 / 512-435-3243 |
CARBOMEDICS PROSTHETIC HEART VALVE SIZER | VALVE SIZERS |
| 3 | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614 US 949-250-2500 / 949-250-2698 |
SIZER, HEART-VALVE, PROSTHESIS | SIZER, HEART-VALVE, PROSTHESIS |
| 4 | GENESEE BIOMEDICAL, INC. 1308 SOUTH JASON ST. DENVER, CO 80223 US 303-777-3000 / 303-777-3000 111 |
ANNULOPLASTY RING SIZER | SIZER, ANNULOPLASTY RING |
| 5 | HEARTPORT, INC. ROUTE 22 WEST SOMERVILLE, NJ 08876 US 908-218-3195 / 908-218-2996 |
PORT-ACCESS VALVE SIZER SET | VALVE SIZER SET |
| 6 | INTUITIVE SURGICAL, INC. 950 KIFER RD. SUNNYVALE, CA 94086 US 408-523-2100 / 408-523-2145 |
ENDOSCOPIC VALVE SIZER | PROSTHETIC HEART VALVE SIZER |
| 7 | MEDICAL CARBON RESEARCH INSTITUTE-DEUTSCHLAND GMBH 11 OSTPASSAGE LANGENHAGEN, D30853 GM 512-339-8000 / 512-339-8000 |
ON-X PROTHETIC HEART VALVE INSTRUMENTS | HEART VALVE SIZERS |
| 8 | MEDTRONIC HEART VALVES 8299 CENTRAL AVE., N.E. SPRING LAKE PARK, MN 55432 US 763-514-4000 / 763-391-9030 |
SIZER OR OBTURATOR | SIZER OR OBTURATOR |
| 9 | MICROSURGICAL LABORATORIES, INC. 11333 CHIMNEY ROCK RD., SUITE # 110-120 HOUSTON, TX 77035 US 713-723-6900 / 713-723-6900 |
PROSTHESIS HEART-VALVE SIZER | PROSTHESIS HEART-VALVE SIZER |
| 10 | ON-X LIFE TECHNOLOGIES, INC. 8200 CAMERON RD., A-196 AUSTIN, TX 78754 US 512-339-8000 / 512-339-8000 |
ON-X PROTHETIC HEART VALVE INSTRUMENTS | HEART VALVE SIZERS |
| 11 | SORIN BIOMEDICA CARDIO S.R.L. VIA CRESCENTINO SALUGGIA (VERCELLI), I-13040 IT 390-161-4871 / 512-435-3266 |
PROSTHETIC HEART VALVE SIZER | VALVE SIZERS |
| 12 | ST. JUDE MEDICAL ONE LILLEHEI PLAZA ST. PAUL, MN 55117 US 651-483-2000 / 651-415-7029 |
ST. JUDE MEDICAL MECHANICAL HEART VALVE SIZER | VARIOUS SIZES AND TYPES OF VALVE SIZERS |
| 13 | SULZER CARBOMEDICS CANADA LTD. 120, 6815 8 STREET N.E. CALGARY, ALBERTA, T2E 7H7 CA 760-929-4300 / 512-435-3211 |
MULTIPLE VALVE SIZERS | VALVE SIZER |
| 14 | THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG 1851 EAST DEERE AVE. SANTA ANA, CA 92705 US 763-514-4000 / 763-391-9030 |
SIZER OR OBTURATOR | SIZER OR OBTURATOR |
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