FDA Product Code MSB: System And Accessories, Isolated Heart, Transport And Preservation
Leading manufacturers include TransMedics, Inc..
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
Cleared
Nov 18, 2022
OCS Lung Donor Flush Set
TransMedics, Inc.
Gastroenterology & Urology
88d
Cleared
Jul 29, 2021
OCS Lung Solution
TransMedics, Inc.
Gastroenterology & Urology
90d
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.
MSB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →