Waves/WCM Sterile Drape
Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
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.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
Record
| 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
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 6 |
| Distribution end date | 2024-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRAPE STERILE PACK – 1drape/bag (included in WCM cassettes kit) | Withdrawn |
Same 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
| 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.
| 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.