| Device Type ID | 84 |
| Device Name | Circulator, Breathing-circuit |
| Regulation Description | Breathing Circuit Circulator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 84 |
| Device | Circulator, Breathing-circuit |
| Product Code | CAG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breathing Circuit Circulator. |
| CFR Regulation Number | 868.5250 [🔎] |
| Device Problems | |
|---|---|
Leak / Splash | 33 |
Melted | 24 |
Crack | 15 |
Split | 11 |
Disconnection | 11 |
Misassembled | 9 |
Hole In Material | 8 |
Infusion Or Flow Problem | 7 |
Connection Problem | 5 |
Device Inoperable | 4 |
Loss Of Or Failure To Bond | 3 |
Failure To Deliver | 3 |
Fitting Problem | 3 |
Detachment Of Device Component | 3 |
Thermal Decomposition Of Device | 2 |
Cut In Material | 2 |
Detachment Of Device Or Device Component | 2 |
Temperature Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Disassembly | 2 |
Occlusion Within Device | 2 |
Suction Problem | 1 |
Material Integrity Problem | 1 |
Torn Material | 1 |
Break | 1 |
Delivery System Failure | 1 |
Device Damaged Prior To Use | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Separation | 1 |
| Total Device Problems | 161 |