Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680933

FEI Number

1000637007

Entity Name

DELTEX MEDICAL LIMITED

City/State/Country

CHICHESTER West Sussex, GB

Establishment Address

TERMINUS RD., CHICHESTER West Sussex PO19 8TX, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Deltex Medical (Owner Number: 9012472)

Owner / Operator Contact Address

TERMINUS ROAD, CHICHESTER, GB-WSX PO19 8TX, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111542

PMA Number

N/A

All Registered Proprietary Names

I2C Doppler Probe (72 hour) I2S Doppler Probe (6 hour) I2P Doppler Probe (24 hour) KDP72 Doppler Probe CardioQ & CardioQ-EDM Roll Stand CardioQ-EDM+ Cardiac Function and Fluid Status Monitoring System CardioQ-EDM Cardiac Function and Fluid Status Monitoring Sys

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2009-10-06
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2015-12-17
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2005-04-04
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2013-11-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-11-04
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2011-11-04
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2011-11-04

Official Correspondent

Chris Shenton

US Agent Details

Donna Connolly Business: Deltex Medical Limited Email: donna.connolly@deltexmedical.com Phone: (864) 7705421

Related Public Records

Same Entity

Deltex Medical

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22

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2184009	MEDTRONIC PERFUSION SYSTEMS	Minneapolis, MN, US
2011171	Sterigenics US LLC	Los Angeles, CA, US
9613067	MEDISTIM ASA	OSLO, NO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680933. Last updated year: 2026. Please use registration number 9680933 when referencing this establishment in official correspondence.