MSB · Class II · 21 CFR 876.5880

FDA Product Code MSB: System And Accessories, Isolated Heart, Transport And Preservation

Leading manufacturers include TransMedics, Inc., Paragonix Technologies, Inc. and Paragonix Technologies.

13
Total
13
Cleared
146d
Avg days
1999
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared System And Accessories, Isolated Heart, Transport And Preservation Devices (Product Code MSB)

13 devices
1–13 of 13
Cleared Nov 18, 2022
OCS Lung Donor Flush Set
K222535
TransMedics, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 29, 2021
OCS Lung Solution
K211314
TransMedics, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 14, 2019
Servator C SALF Solution
K190063
S.A.L.F. Spa
Gastroenterology & Urology · 211d
Cleared Oct 19, 2018
Paragonix SherpaPak Cardiac Transport System
K182735
Paragonix Technologies
Gastroenterology & Urology · 21d
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194
Paragonix Technologies, Inc.
Gastroenterology & Urology · 65d

About Product Code MSB - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code MSB since 1999, with 13 receiving FDA clearance (average review time: 146 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.