510(k) K192869
- Device
- SherpaPak Lung Preservation System , SherpaPak Liver Transport System
- Applicant
- Pragonix Technologies
- 510(k) number
- K192869
- Product code
- KDN
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2020-01-16
- Date received
- 2019-10-07
- Regulation
- 876.5880
- Classification name
- System, Perfusion, Kidney
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Anderson
- Address
- Suite 408, 639 Granite St. Braintree MA US 02184 02184
FDA Registration Numbers#
- 1420032
- 1720929
- 2132588
- 3020224798
- 2183744
- 3008998256
- 3000143502
- 3027669473
- 9615922
- 3007685782
- 3008388260
- 1450662
- 3010005578
- 3014498869
- 3010163695
- 3021739803
- 1721676
- 3017223202
- 3038515260
- 3007583504
- 3010765841
- 3007710603
- 3005694677
- 3011292417
- 3031884833
- 3011175555
- 3031600052
- 2123774
- 3014967969
- 1067143
- 3010680515
- 3017298490
- 3010034260
- 3024820181
- 1423929
- 3004068499
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254305 | BAROguard Donor Lung Preservation System | Paragonix Technologies, Inc. | 2026-01-30 |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) | Bridge TO Life | 2025-06-17 |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation Solution | Traferox Technologies, Inc. | 2025-05-01 |
| K243998 | DCX Disposable Cassette (DCX) | Institut Geroges Lopez | 2025-04-25 |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001) | Bridge TO Life | 2025-03-31 |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) | Bridge TO Life | 2025-03-26 |
| K240650 | LungProtect | Traferox Technologies, Inc. | 2024-11-26 |
| K234060 | KIDNEYvault Portable Renal Perfusion System | Paragonix Technologies | 2024-10-23 |
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023-09-21 |
| K223874 | BAROguard | Paragonix Technologies | 2023-08-15 |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | 2022-01-20 |
| K211224 | RM4 Control Unit | Institut Georges Lopez | 2021-10-15 |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | 2021-08-19 |
| K203262 | Cannula for Organ Perfusion | Bridge TO Life, Ltd. | 2021-07-01 |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | 2020-07-02 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases