PFAClass II
Non-invasive Central Venous Manometer
Cardiovascular · 21 CFR 870.1140
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.
MDR events117All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances2All time
Recent MDR events
117 adverse event reports on file
- Inset GuardJul 30, 2026MalfunctionUnomedical A/s8021545-2026-29268
- Inset GuardJul 30, 2026MalfunctionUnomedical A/s8021545-2026-29297
- Inset GuardJul 30, 2026MalfunctionUnomedical A/s8021545-2026-29412
- Inset GuardJul 30, 2026MalfunctionUnomedical A/s8021545-2026-29414
- Inset GuardJul 30, 2026MalfunctionUnomedical A/s8021545-2026-29415
- Quick SetJul 30, 2026MalfunctionUnomedical Devices S.a De C.v3003442380-2026-60218
- Quick SetJul 30, 2026MalfunctionUnomedical Devices S.a De C.v3003442380-2026-61475
- OTHER ACCESSORIESJul 28, 2026MalfunctionUnomedical Devices S.a De C.v3003442380-2026-58411
- OTHER ACCESSORIESJul 28, 2026MalfunctionUnomedical Devices S.a De C.v3003442380-2026-58965
- OTHER ACCESSORIESJul 28, 2026MalfunctionUnomedical Devices S.a De C.v3003442380-2026-58913
Event type breakdown
Malfunction65
Injury52
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code