CATHETER, SEPTOSTOMY~CARDIOVASCULAR MANUFACTURED BY EDWARDS LIFESCIENCES TECHNOLOGY SARL

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Request for Information Form	Contact Information
Company Name	EDWARDS LIFESCIENCES TECHNOLOGY SARL
Address	STATE RD. 402 N.KM 1.4
City, State, Zip	ANASCO, PR 00610
Country	US
FDA Owner/Operator Phone	949-250-2500
FDA Medical Specialty Code	CV - Cardiovascular
FDA Product Code	DXF
FDA Classification Name	CATHETER, SEPTOSTOMY
FDA Device Classification Code	Standards
FDA Regulation Number	870.5175
FDA Common Generic Name	ATRIOSEPTOSTOMY CATHETER
FDA Proprietary Device Name	CATHETER, SEPTOSTOMY~CARDIOVASCULAR
FDA Owner / Operator Number	9040666
FDA Owner / Operator Name	EDWARDS LIFESCIENCES, LLC.
FDA Establishment Registration Number	2648045
FDA Registered Establishment Name	EDWARDS LIFESCIENCES TECHNOLOGY SARL
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	02-28-03
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	BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E MISSISSAUGA, ONTARIO, L4W 5S4 CA 514-488-9801 / 905-602-4875x222	NYKANEN RF SEPTOSTOMY CATHETER	NYKANEN RF SEPTOSTOMY CATHETER
2	COOK, INC. 750 DANIELS WAY PO BX 489 BLOOMINGTON, IN 47402 US 812-339-2235 / 812-339-2235	BLADE SEPTOSTOMY CATHETER	SEPTOSTOMY CATHETER
3	MEDTRONIC VASCULAR 35-37A CHERRY HILL DR DANVERS, MA 01923 US 763-514-4000 / 978-777-0042	CATHETER, SEPTOSTOMY	CATHETER, SEPTOSTOMY
4	NUMED CANADA, INC. 45 SECOND ST. CORNWALL, ONTARIO, K6J 1G3 CA 613-936-2592 / 315-328-4491	Z-5 ATRIOSEPTOSTOMY	SEPTOSTOMY CATHETER