Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013267343

FEI Number

3013267343

Entity Name

Chalice Medical Ltd

City/State/Country

Worksop Nottinghamshire, GB

Establishment Address

Manton Wood Enterprise Park, Worksop Nottinghamshire S80 2RS, GB

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Chalice Medical Limited (Owner Number: 10059431)

Owner / Operator Contact Address

Units 1-2 Manton Wood Enterprise Park, Drayton Court, Worksop, GB-NTT S80 2RS, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201642

PMA Number

N/A

All Registered Proprietary Names

CMO8 Adult PMP Oxygenator with Tubing Pack Holder for Standalone Paragon Adult, Paediatric & Infant Oxygenator Holder for Standalone CMO8 Adult Oxygenator Paragon Adult Maxi PMP Oxygenator Paragon Adult Maxi PMP Oxygenator with Tubing Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-11-13
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-11-13
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2023-11-13
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2020-05-15
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2020-04-09
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2020-04-09
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2021-01-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-01-28
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2021-01-28

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Chalice Medical Limited

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
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Similar Registrations

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9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX
2528981	LYNX Medical Pennsylvania	ERIE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013267343. Last updated year: 2026. Please use registration number 3013267343 when referencing this establishment in official correspondence.