SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180194 FDA 510(k)
- FDA Product Code
- MSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5880 FDA 510(k)
- Regulation Number
- 876.5880 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System are classified as System and Accessories, Isolated Heart, Transport and Preservation and System and Accessories, Isolated Kidney, Transport and Preservation, designed for the static hypothermic preservation of donor organs during transport. These systems provide a controlled environment to maintain organ viability through secure containment and temperature regulation, ensuring safe transit from donor to recipient. The devices are engineered to mitigate risks associated with prolonged organ transport by leveraging advanced cooling and monitoring technologies.
These systems are intended for single-use and are supplied sterile, requiring no additional preparation beyond standard sterile handling procedures. They are classified under Device Class II and comply with FDA 510(k) clearance (K180194) as substantially equivalent to predicate devices. The systems are designed for use in clinical settings such as transplant centers and are regulated under 21 CFR 876.5880. Storage instructions are not specified in the regulatory data, but standard sterile storage conditions apply.
Frequently asked questions
What types of organs are the SherpaPak systems designed to transport, and how do they maintain viability during transit?
The SherpaPak systems are specifically designed for the static hypothermic preservation of donor hearts and kidneys during transport. They achieve this by providing a controlled, secure environment that regulates temperature to help maintain organ viability. The systems are engineered to minimize risks associated with prolonged transport by combining advanced cooling and containment technologies, ensuring organs remain stable from the donor site to the recipient.
Are the SherpaPak Cardiac and Kidney Transport Systems intended for reuse, or are they single-use devices?
The SherpaPak systems are explicitly designed for single-use only. They are supplied sterile and require no additional preparation beyond standard sterile handling procedures, which aligns with their intended use in clinical settings like transplant centers.
What storage conditions should be followed for the SherpaPak systems before use?
While specific storage instructions aren’t detailed in the regulatory data, the systems are supplied sterile, so they should be stored under standard sterile conditions. This typically means keeping them in a clean, dry environment, protected from contamination, and following manufacturer guidelines for sterile medical devices.
How are the SherpaPak systems regulated, and what does their classification mean for clinical use?
The SherpaPak systems are classified as Device Class II and have received FDA 510(k) clearance (K180194), meaning they are deemed substantially equivalent to predicate devices. This classification ensures they meet FDA safety and effectiveness standards for use in clinical settings, such as transplant centers, under the regulatory framework of 21 CFR 876.5880.
Are there different models or sizes available for the SherpaPak systems, and how would I determine the correct fit for an organ?
The regulatory data does not specify distinct models or sizes for the SherpaPak systems, but they are designed to accommodate donor hearts and kidneys. Selection would typically be based on the organ type (cardiac or kidney) and compatibility with standard transplant protocols. For precise sizing or model selection, consulting the manufacturer’s instructions or clinical guidelines for organ transport is recommended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Paragonix SherpaPak CTS | A New Standard in Donor Heart Preservation, Clinical Evidence Points to Paragonix SherpaPak as Potential Solution ..., SherpaPak - Paragonix - PDF Catalogs | Technical Documentation
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180194 | Class II | Active |
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Manufacturer
- Manufacturer
- Paragonix Technologies, Inc.
Sources (1)
- FDA 510(k) K180194 24 fields · synced Oct 6, 2026