Who else makes this device?

Name: WCM Kit
Brand: WCM Kit

Gastroenterology & Urology › TherapeuticSystem, Perfusion, Kidney

WCM Kit

DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters…

Registry build 21.09.26

DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes

1manufacturer

1catalogue number

1510(k) clearance

1recall

Who Else Makes It

Registered in Fujian. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KDN
Manufacturer	City	Province	Registered as	Device types
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16

Record

Regulatory record for WCM Kit
Listed by	Waters Medical Systems, LLC, United States
FDA product code	KDN
Device type	System, Perfusion, Kidney
Device class	Class 2
Regulation	21 CFR 876.5880
Establishment	Complaint-file establishment, Manufacturer
510(k)	K111521
Record published	2017-02-12
Record revised	2024-12-05 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Packaging	Case of 6
Distribution end date	2024-09-02

Catalogue Numbers

Catalogue numbers for WCM Kit
Catalogue number	Size	Status
WCM Kit		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BAROguard	Paragonix Technologies, Inc.	7
LifePort® Kidney Transporter	Organ Recovery Systems, Inc.	5
KidneyVault	Paragonix Technologies, Inc.	5
KidneyVault Portable Renal Perfusion System	Paragonix Technologies, Inc.	3
PancreasPak	Paragonix Technologies, Inc.	3
Perfadex Plus®	Xvivo Perfusion AB	3
Perfusion Cannula	Institut Georges Lopez	3
Belzer UW Cold Storage Solution	Bridge to Life Ltd	3
Belzer UW Cold Storage Solution	Preservation Solutions, Inc.	3
X°Port Lung Preservation Solution	Traferox Technologies Inc.	3
LUNGguard	Paragonix Technologies, Inc.	2
Servator B Salf Solution	S.a.l.f. SPA Laboratorio Farmacologico	2

Showing 12 of 78. All products under System, Perfusion, Kidney

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K111521	2012-02-16

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of WCM Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Waters Medical Systems, LLC	510(k) number	2022-03-21	Class II	Process control	There is a potential for the WCM cassette pump head leaking solution.	75 cases (6ct)	2024-08-16

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.