Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2648045

FEI Number

2648045

Entity Name

EDWARDS LIFESCIENCES TECHNOLOGY SARL

City/State/Country

ANASCO, PR, US

Establishment Address

STATE ROAD 402, KM 1.4, Industrial Park, ANASCO, PR 00610, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton, Dickinson and Company (Owner Number: 10093301)

Owner / Operator Contact Address

17200 Laguna Canyon Road, Irvine, CA 92618, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fogarty Venous Thrombectomy Catheter SWAN-GANZ SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size PreSep INTRO-FLEX Introducer SWAN-GANZ Thermodilution Catheter, VIP and VIP+, True Size Fogarty PreSep AVA HF INTRO-FLEX Introducer SWAN-GANZ Chandler Transluminal V-Pacing Prove- D98100/670923010 Chandler Transluminal V-Pacing Prove- D98500/670924010 Flex-Tip Tranluminal A-Pacing Probe- D98100/670923010 Flex-Tip Tranluminal A-Pacing Probe- D98500/670924010 SWAN-GANZ Polymer Blend True Size ControlCath Thermodilution Catheters SWAN-GANZ Fogarty Swan-Ganz COO/SVO2 SWAN-GANZ Continuous Cardiac Output Thermodilution Catheter SWAN-GANZ Right Heart Ejection Fraction Thermodilution and Oximetry Catheter Double Lumen Oximetry Catheter Swan-Ganz HI-SHORE Vantex Multi Med PediaSat Oximetry Catheter Swan Ganz Catheters Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts VolumeView Multi-Med PreSep PreSep Oximetry Catheters Edwards Oximetry Central Venous Catheter PediaSat Oximetry Catheter Fogarty Graft Thrombectomy Catheter Fogarty Corkscrew Catheter Swan Ganz Catheters Fogarty Swan-Ganz Catheters VASCULAR CLAMP Fogarty 6mm Spring Clip Fogarty VolumeView sensor FloTrac Sensor FloTrac Jr Sensor Acumen IQ sensor Fogarty Occlusion Catheter SWAN-GANZ Continuous Cardiac Output/End Diastolic Volume Thermodilution Catheter Fogarty Fogarty Arterial Embolectomy Catheter Fogarty Biliary Balloon Probe SWAN-GANZ Swan-Ganz Pacing-TD Catheter Swan-Ganz Bipolar Pacing Catheter CO-SET Thru-lumen Embolectomy catheter Fogarty Laparoscopic Cholangiography Catheter Vantex EOCVC Kit Edwards Oximetry Central Venous Catheter Kit SWAN-GANZ SWAN-GANZ SWAN-GANZ Swan Ganz Catheters Fogarty

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-02-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-05-06
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2025-05-06
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-06
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-02-13
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2026-04-24
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2026-06-09
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2025-05-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-02-13
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-05-06
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2025-05-06
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2025-05-06
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-05-06
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2025-04-28
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2025-05-06
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2025-05-06
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-05-06
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2026-04-24
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-04-24
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2026-04-24
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-05-06
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-05-06
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-02-13
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2025-05-06
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2025-05-06
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2025-05-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-05-06
GCA	Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	Gastroenterology, Urology	Class 2	876.5010	2025-05-06

Official Correspondent

Karen O'Leary

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Becton, Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3042941992	Edwards Lifesciences Holding B.V.	AMSTERDAM Noord-Holland, NL
9615817	CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, DO
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K833836	Instrumentation Laboratory CO	IL HEPARINIZED FLOW DIRECTED THERMAL	1984-02-04
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2648045. Last updated year: 2026. Please use registration number 2648045 when referencing this establishment in official correspondence.