ANGIOSCOPE 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	LYK
FDA Classification Name	ANGIOSCOPE
FDA Device Classification Code	Standards
FDA Regulation Number	876.1500
FDA Common Generic Name	ANGIOSCOPE
FDA Proprietary Device Name	ANGIOSCOPE
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	AIZU OLYMPUS CO., LTD. 500 AZA MURANISHI OOAZA-IIDERA MONDEN-CHO AIZUWAKAMATSU-SHI FUKUSHIMA, 965-8520 JA / 484-896-5688	VARIOUS MODELS OF ANGIOSCOPE AND ACCESSORIES	ANGIOSCOPES AND ACCESSORIES
2	APPLIED MEDICAL RESOURCES CORP. 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA, CA 92688 US 949-713-8000 / 949-713-8000 8326	ANGIOSCOPIC CATHETER	ANGIOSCOPIC CATHETER
3	CARDIO-OPTICS, INC. 2425 55TH ST., SUITE 100 BOULDER, CO 80301 US 720-406-1560 / 720-406-1560	CORONARY SINUS ACCESS SYSTEM	ANGIOSCOPE
4	KARL STORZ ENDOSCOPY-AMERICA, INC. 91 CARPENTER HILL RD. CHARLTON, MA 01507 US 49-74-617080 / 800-421-0837 4201	KARL STORZ VASCULAR FIBERSCOPE	FLEXIBLE ENDOSCOPE
5	KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201	KARL STORZ VASCULAR FIBERSCOPE	FLEXIBLE ENDOSCOPE
6	OLYMPUS MEDICAL SYSTEMS CORPORATION 2951 ISHIKAWA-CHO HACHIOJI-SHI, 192-8507 JA / 484-896-5688	OLYMPUS ANGIOSCOPES & ACCESSORIES	ANGIOSCOPES, LIGHT SOURCES, VALVULOTOMES, AND ACCESSORIES
7	OMEGA LASER SYSTEMS LTD. 2 DEANS HALL BUSINESS PARK OAK ROAD, LITTLE MAPLESTEAD HALSTEAD, ESSEX, CO9 2RT UK 44-178-7477551 / 44-178-7477551	OMEGA ANGIOSCOPE	ANGIOSCOPE
8	SHIRAKAWA OLYMPUS CO., LTD. 3-1, AZA OOKAMIYAMA OOAZA ODAKURA, NISHIGO-MURA NISHISHIRAKAWA-GUN FUKUSHIMA, 961-8061 JA / 484-896-5688	OLYMPUS ANGIOSCOPES & ACCESSORIES	ANGIOSCOPES, LIGHT SOURCES, VALVULOTOMES, AND ACCESSORIES