| Device Type ID | 210 |
| Device Name | Apparatus, Suction, Patient Care |
| Regulation Description | Patient Care Suction Apparatus. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWM |
| 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 | 210 |
| Device | Apparatus, Suction, Patient Care |
| Product Code | DWM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Patient Care Suction Apparatus. |
| CFR Regulation Number | 870.5050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCKET MEDICAL PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 26 |
Valve | 18 |
Product Quality Problem | 6 |
Suction Problem | 6 |
Device Inoperable | 5 |
Crack | 5 |
Leak / Splash | 4 |
Disconnection | 3 |
Detachment Of Device Component | 2 |
Cap | 2 |
Catheter | 2 |
Component Missing | 1 |
Connection Problem | 1 |
Patient-Device Incompatibility | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Sensing Problem | 1 |
Material Integrity Problem | 1 |
Material Deformation | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Material Separation | 1 |
Inadequate Or Insufficient Training | 1 |
Connector | 1 |
Decrease In Suction | 1 |
Fluid Leak | 1 |
Improper Flow Or Infusion | 1 |
| Total Device Problems | 94 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Pfm Medical Inc | II | Dec-12-2014 |