OBIClass II
Catheter, Pressure Monitoring, Cardiac
Cardiovascular · 21 CFR 870.1200
To measure pressure within the cardiovascular system.
MDR events22All time
Recalls1All time
Registered firms7Currently listed
510(k) clearances1All time
Recent MDR events
22 adverse event reports on file
- ACISTJul 16, 2025Malfunction2134243-2025-00013
- ACISTJul 6, 2023MalfunctionAcist Medical Systems, Inc.2134243-2023-00008
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMSep 16, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-19539
- ACISTMay 19, 2022MalfunctionAcist Medical Systems, Inc.2134243-2022-00009
- ACISTApr 27, 2022InjuryAcist Medical Systems, Inc.2134243-2022-00006
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMFeb 24, 2022InjurySmiths Medical International, Ltd.3012307300-2022-04093
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMFeb 24, 2022InjurySmiths Medical International, Ltd.3012307300-2022-04095
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMFeb 24, 2022InjurySmiths Medical International, Ltd.3012307300-2022-04097
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMFeb 24, 2022InjurySmiths Medical International, Ltd.3012307300-2022-04099
- MEDEX LOGICAL PRESSURE MONITORING SYSTEMFeb 24, 2022InjurySmiths Medical International, Ltd.3012307300-2022-04101
Event type breakdown
Injury15
Malfunction6
Death1
Recalls
1 recall events for this product code
Registered firms
7 firms currently registered for this product code
510(k) clearances
1 clearances for this product code