PMSClass II
Peripheral Intravenous (piv) Infiltration Monitor
General Hospital · 21 CFR 880.5725
Peripheral catheter monitor (PIV) indicated for the detection of subcutaneous infiltrations and extravasations.
MDR events1All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances5All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
5 clearances for this product code
- Ivwatch, LLCMar 15, 2024
K233881 · ivWatch® Model 400
- Ivwatch, LLCAug 24, 2022
K222212 · ivWatch Model 400
- Ivwatch, LLCJul 2, 2020
K192385 · ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable
- Ivwatch, LLCDec 22, 2016
K162478 · ivWatch
- Ivwatch, LLCFeb 11, 2016
K153605 · ivWatch Model 400