MSB · System And Accessories, Isolated Heart, Transport And Preservation
Gastroenterology, Urology · 21 CFR 876.5880 · Class 2
Overview
| Product Code | MSB |
|---|---|
| Device Name | System And Accessories, Isolated Heart, Transport And Preservation |
| Regulation | 21 CFR 876.5880 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222535 | OCS Lung Donor Flush Set | TransMedics, Inc. | Nov 18, 2022 | SESE |
| K211314 | OCS Lung Solution | TransMedics, Inc. | Jul 29, 2021 | SESE |
| K190063 | Servator C SALF Solution | S.A.L.F. Spa | Aug 14, 2019 | SESE |
| K182735 | Paragonix SherpaPak Cardiac Transport System | Paragonix Technologies | Oct 19, 2018 | SESE |
| K180194 | SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System | Paragonix Technologies, Inc. | Mar 30, 2018 | SESE |
| K143074 | Sherpa Pak Cardiac Transport System | Paragonix Technologies, Inc. | Nov 25, 2014 | SESK |
| K133432 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | Feb 21, 2014 | SESE |
| K123326 | SHERPA PAK CARDIAC TRANSPORT SYSTEM | Paragonix Technologies, Inc. | Feb 6, 2013 | SESE |
| K081997 | PERFADEX WITH THAM | Vitrolife Sweden AB | Oct 9, 2008 | SESE |
| K032794 | CUSTODIOL | Dr. Franz Kohler Chemie GmbH | Apr 5, 2004 | SESE |
| K022730 | PERFADEX SOLUTION FOR LUNG PRESERVATION | Vitrolife AB | Oct 27, 2003 | SESE |
| K000881 | PERFADEX SOLUTION FOR ORGAN PRESERVATION | Vitrolife Sweden AB | Mar 8, 2001 | SESE |
| K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | Sangstat Medical Corp. | Aug 5, 1999 | SESE |
Top Applicants
- Paragonix Technologies, Inc. — 4 clearances
- TransMedics, Inc. — 2 clearances
- Vitrolife Sweden AB — 2 clearances
- Dr. Franz Kohler Chemie GmbH — 1 clearance
- Paragonix Technologies — 1 clearance
