CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG

FDA Device Registration & Listing · HAINA San Cristobal, DO · Registration 9615817

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615817
FEI Number
3003081151
Entity Name
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG
City/State/Country
HAINA San Cristobal, DO
Establishment Address
PARQUE INDUSTRIAL ITABO, KM. 18.5 CARR. SANCHEZ, HAINA San Cristobal --, DO
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
N
Expiration Date (Year)
2026
510(k) Number
K173586
PMA Number
N/A

All Registered Proprietary Names

Swan Ganz Catheters ClearSight finger cuff Accumen IQ finger cuff Fogarty VAMP VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION ClearSight finger cuff CO-SET Pressure Controller EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Pressure Controller Kit Cuffs or ClearSight System EV1000 Clinical Platform Fogarty FloTrac Sensor FloTrac Jr Sensor Transducer, blood-pressure, extravascular VolumeView sensor Acumen IQ sensor HemoSphere Pressure Cable HemoSphere ClearSight Module VitaWave Plus finger cuff HemoSphere Vita Monitor HemoSphere Technology Module HemoSphere Vita Technology Module Acumen IQ Plus Finger Cuff HemoSphere Advanced Monitor Smart Pressure Controller HemoSphere VitaWave module DISPOSABLE PRESSURE DOME Dome TruWave Disposable Pressure Transducer Transducers Pressure Monitoring Kit with TruWave Disposable Pressure VolumeView sensor FloTrac Sensor FloTrac Jr Sensor Acumen IQ sensor FloTrac Jr sensor ClearSight Jr finger cuff Swan-Ganz Jr catheter HemoSphere VASCULAR CLAMP Fogarty 6mm Spring Clip Fogarty HemoSphere Vita Monitor Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter HemoSphere Technology Module Acumen IQ sensor with 60” (152cm) pressure tubing and Acumen IQ fluid meter, 5-pack HemoSphere Advanced Monitor ViewFinder Remote Acumen IQ sensor with 84” (213cm) pressure tubing, Acumen IQ fluid meter, 5-pack HemoSphere Vita Technology Module HemoSphere Pressure Cable Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult Pressure Controller Kit Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult, 5-pack HemoSphere Oximetry Cable HemoSphere ClearSight Module HemoSphere Swan-Ganz Module Acumen IQ sensor with 60” (152cm) pressure tubing, Acumen IQ fluid meter and VAMP Adult with TruWave DPT, 5-pack HemoSphere ForeSight Oximeter Cable Acumen AFM Cable Heart Reference Sensor HemoSphere VitaWave Module Acumen IQ sensor with 84” (213cm) pressure tubing with Acumen IQ fluid meter Acumen IQ Fluid Meter Acumen IQ finger cuff Acumen IQ finger cuff adult VitaWave finger cuff adult Swan Ganz Catheters CO-SET FORE-SIGHT ELITE PRE-AMP CABLE 4m and 6.5m FORE-SIGHT ELITE TISSUE OXIMETER SENSORS, ForeSight Sensors FORE-SIGHT ELITE Tissue Oximeter TruWave Disposable Pressure Transducer Swan Ganz Catheters VAMP Venous/Arterial Blood Management Protection System TruWave™ Disposable Pressure Transducers Disposable Pressure Transducer TruWave Disposable Pressure Transducer Flotrac Sensor-MHD6AZ Flotrac Sensor-MHD6AZ5 Flotrac Sensor-MHD6AZA VolumeView Sensor-VLV8R5 Flotrac Sensor-MHD8S102 Flotrac Sensor-MHD6AZ VolumeView Sensor-VLV6R5 Flotrac Sensor-MHD6C502 Acumen IQ Sensor Flotrac Sensor-MHD8 Flotrac Sensor-MHD65 Flotrac Sensor-MHD6 Flotrac Sensor-MHD8 Flotrac Sensor-MHD85 Flotrac Sensor-MHD8C503 VAMP Optima closed blood sampling system Fogarty Softjaw Spring Clip VAMP Plus Venous/Arterial Blood Management Protection System VAMP Venous/Arterial Blood Management Protection System TruClip VAMP Venous/Arterial Blood Management Protection System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYG Catheter, Flow Directed Cardiovascular Class 2 870.1240 2026-04-23
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DXE Catheter, Embolectomy Cardiovascular Class 2 870.5150 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-06-04
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DXG Computer, Diagnostic, Pre-Programmed, Single-Function Cardiovascular Class 2 870.1435 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2026-04-24
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-09-30
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-04-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 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
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2025-05-06
QAQ Adjunctive Predictive Cardiovascular Indicator Cardiovascular Class 2 870.2210 2025-05-06
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2025-05-06
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
QMS Adjunctive Open Loop Fluid Therapy Recommender Cardiovascular Class 2 870.5600 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2025-05-06
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2025-05-06
DQE Catheter, Oximeter, Fiber-Optic Cardiovascular Class 2 870.1230 2025-05-06
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-05-06
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 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
KRB Probe, Thermodilution Cardiovascular Class 2 870.1915 2026-04-24
MUD Oximeter, Tissue Saturation Cardiovascular Class 2 870.2700 2025-05-06
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 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
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-04-24
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-04-23
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-02-10
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2025-06-04
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2025-06-04
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-06-04
DXC Clamp, Vascular Cardiovascular Class 2 870.4450 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-02-13
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-02-13
FOX Stand, Infusion General Hospital Class 1 880.6990 2025-05-06
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2026-02-13
DXO Transducer, Pressure, Catheter Tip Cardiovascular Class 2 870.2870 2026-02-13

Official Correspondent

Karen O'Leary

US Agent Details

Karen O'Leary Business: Becton, Dickinson & Company Email: karen.oleary2@bd.com Phone: (949) 6109179

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
2648045 EDWARDS LIFESCIENCES TECHNOLOGY SARL ANASCO, PR, US
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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0002-2016 Biosense Webster, Inc. 2
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05 Siemens Medical Solutions USA, Inc 2
AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615817. Last updated year: 2026. Please use registration number 9615817 when referencing this establishment in official correspondence.
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