| Device Type ID | 80 |
| Device Name | Apparatus, Autotransfusion |
| Regulation Description | Autotransfusion Apparatus. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 80 |
| Device | Apparatus, Autotransfusion |
| Product Code | CAC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Autotransfusion Apparatus. |
| CFR Regulation Number | 868.5830 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FRESENIUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRESENIUS KABI AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HAEMONETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HAEMONETICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SORIN GROUP DEUTSCHLAND GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TELEFLEX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TELEFLEX MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Infusion Or Flow Problem | 30 |
Fluid Leak | 16 |
Leak / Splash | 15 |
Break | 13 |
Suction Problem | 11 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 10 |
Device Operates Differently Than Expected | 8 |
Insufficient Information | 7 |
Adverse Event Without Identified Device Or Use Problem | 6 |
Coagulation In Device Or Device Ingredient | 5 |
Defective Component | 5 |
Detachment Of Device Component | 5 |
Disconnection | 4 |
Thermal Decomposition Of Device | 4 |
Disassembly | 4 |
Tear, Rip Or Hole In Device Packaging | 3 |
Kinked | 3 |
Biocompatibility | 3 |
Crack | 3 |
Detachment Of Device Or Device Component | 3 |
Inadequate Filtration Process | 3 |
Air Leak | 3 |
Unsealed Device Packaging | 3 |
Device Issue | 3 |
Hole In Material | 2 |
Material Integrity Problem | 2 |
No Flow | 2 |
Component Missing | 2 |
Device Tipped Over | 1 |
Difficult To Open Or Close | 1 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 1 |
Use Of Device Problem | 1 |
Invalid Sensing | 1 |
Device Displays Incorrect Message | 1 |
Inappropriate Shock | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
Fire | 1 |
Fracture | 1 |
Tube | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Subassembly | 1 |
Partial Blockage | 1 |
Failure To Shut Off | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Decrease In Suction | 1 |
| Total Device Problems | 198 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atrium Medical Corporation | II | Feb-15-2017 |
| 2 | Atrium Medical Corporation | II | Jul-01-2014 |
| 3 | Atrium Medical Corporation | II | Jan-14-2014 |
| 4 | Fenwal Inc | II | Mar-26-2019 |
| 5 | Haemonetics Corporation | II | Jan-28-2019 |
| 6 | Haemonetics Corporation | II | Aug-30-2018 |
| 7 | Medtronic Perfusion Systems | II | Jan-29-2019 |
| 8 | Stryker Instruments Div. Of Stryker Corporation | II | May-01-2015 |
| 9 | Teleflex Medical | II | Apr-28-2016 |