| Device Type ID | 758 |
| Device Name | Transducer, Blood-pressure, Extravascular |
| Regulation Description | Extravascular Blood Pressure Transducer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DRS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 758 |
| Device | Transducer, Blood-pressure, Extravascular |
| Product Code | DRS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Extravascular Blood Pressure Transducer. |
| CFR Regulation Number | 870.2850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CENTURION MEDICAL PRODUCTS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEGANIA SILICONE, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MIRADOR BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 91 |
Detachment Of Device Component | 48 |
Disconnection | 41 |
Device Subassembly | 37 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 26 |
Material Separation | 17 |
Pressure Tubing | 15 |
Air Leak | 10 |
Fluid Leak | 9 |
Break | 8 |
Tube | 8 |
Device Issue | 7 |
Failure To Reset | 7 |
Transducer | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Display Or Visual Feedback Problem | 5 |
Detachment Of Device Or Device Component | 5 |
Particulates | 5 |
Loss Of Or Failure To Bond | 4 |
Output Problem | 4 |
Device Misassembled During Manufacturing / Shipping | 3 |
Connection Problem | 3 |
Tear, Rip Or Hole In Device Packaging | 3 |
Device Component Or Accessory | 3 |
Failure To Prime | 2 |
Difficult To Remove | 2 |
Infusion Or Flow Problem | 2 |
Crack | 2 |
Loose Or Intermittent Connection | 1 |
Blood Pooling | 1 |
Connector | 1 |
Monitor | 1 |
Partial Blockage | 1 |
Reset Problem | 1 |
Separation Failure | 1 |
Plunger | 1 |
Cable | 1 |
Cap | 1 |
Migration Or Expulsion Of Device | 1 |
Valve | 1 |
Decoupling | 1 |
Syringe | 1 |
Air Eliminator, Defective | 1 |
Incorrect Measurement | 1 |
Stopcock Valve, Failure Of | 1 |
Physical Property Issue | 1 |
Catheter | 1 |
| Total Device Problems | 397 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical, Inc. | II | Mar-28-2019 |
| 2 | ICU Medical, Inc. | II | Nov-15-2016 |
| 3 | ICU Medical, Inc. | II | Sep-15-2016 |
| 4 | ICU Medical, Inc. | II | Aug-07-2014 |