VALVULOTOME MANUFACTURED BY EDWARDS LIFESCIENCES, LLC.

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Request for Information Form	Contact Information
Company Name	EDWARDS LIFESCIENCES, LLC.
Address	ONE EDWARDS WAY
City, State, Zip	IRVINE, CA 92614
Country	US
FDA Owner/Operator Phone	949-250-2500
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	MGZ
FDA Classification Name	VALVULOTOME
FDA Device Classification Code	Standards
FDA Regulation Number	870.4885
FDA Common Generic Name	ANGIOSCOPIC VALVULOTOME
FDA Proprietary Device Name	VALVULOTOME
FDA Owner / Operator Number	9040666
FDA Owner / Operator Name	EDWARDS LIFESCIENCES, LLC.
FDA Establishment Registration Number	2015691
FDA Registered Establishment Name	EDWARDS LIFESCIENCES, LLC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-26-02
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	AOMORI OLYMPUS CO., LTD. 2-248-1, OKKONOKI KUROISHI-SHI, AOMORI-KEN, 036-0357 JA / 484-896-5688	VALVULOTOME	VARIOUS TYPES OF VALVUTOMES
2	BIOMET MICROFIXATION, INC. 1520 TRADEPORT DR. JACKSONVILLE, FL 32218 US 800-874-7711 / 904-741-9258	MULTIPLE	VALVULOTOME
3	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 5 SUNNEN DR. ST. LOUIS, MO 63143 US 847-689-8410 / 847-578-6442	LEATHER VALVULOTOME	VARIOUS
4	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1240 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	LEATHER VALVULOTOME	VARIOUS
5	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES 1430 WAUKEGAN RD. MCGAW PARK, IL 60085 US 847-689-8410 / 847-578-6442	LEATHER VALVULOTOME	VARIOUS
6	CARDIOSOURCE 3411 MANDEVILLE CANYON RD. BRENTWOOD, CA 90049 US 310-471-8845 / 310-471-8845	VALVULOTOME	VALVULOTOME
7	DIMEDA INSTRUMENTE GMBH GANSACKER 58 TUTTLINGEN, D-78502 GM 49-74-62-9461-0 / 49-74-62-9461-0	MULTIPLE	VARIOUS MODELS OF VALVULOTOMES
8	LEMAITRE VASCULAR, INC. 63 2ND AVENUE BURLINGTON, MA 01803 US 781-221-2266 / 781-221-2266 105	EXPANDABLE LEMAITRE VALVULOTOME	VALVULOTOME
9	MILTEX, INC. 589 DAVIES DRIVE YORK, PA 17402 US 609-275-0500 / 717-840-3409	MILTEX	VALVULOTOME, VARIOUS MODELS
10	OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688	VALVULOTOME	VARIOUS TYPES OF VALVUTOMES