Product code CAC
- Device name
- Apparatus, Autotransfusion
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5830
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024-08-16 |
| K240426 | Aventus Clot Management System | Inquis Medical | 2024-05-14 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | 2024-04-29 |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | 2023-07-14 |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | 2023-02-17 |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | 2022-11-15 |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | Atrium Medical Corporation | 2021-09-03 |
| K210862 | Hemafuse System | Sisu Global Health | 2021-07-29 |
| K210176 | FlowSaver Blood Filter | Inari Medical | 2021-07-22 |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG | 2021-02-11 |
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | 2020-06-01 |
| K192368 | CATSmart | Fresenius Kabi AG | 2019-09-27 |
| K180831 | CATSmart | Fresenius Kabi AG | 2018-12-10 |
| K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | 2018-08-22 |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | 2017-01-03 |
| K160735 | CATSmart | Fresenius Kabi AG | 2016-09-16 |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | 2016-05-24 |
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | 2014-10-23 |
| K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | 2014-10-21 |
| K131553 | XTRA | Sorin Group Deutschland GmbH | 2014-03-21 |
| K130043 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | 2013-02-12 |
| K120953 | PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM | Tlelflex Medical, Inc. | 2012-12-10 |
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2012-10-25 |
| K120586 | CELL SAVER ELITE | Haemonetics Corp. | 2012-05-22 |
| K112245 | XTRA | Sorin Group Italia S.R.L. | 2011-09-06 |
| K110782 | XVAC | Sorin Group Italia S.R.L. | 2011-04-07 |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Haemonetics Corp. | 2010-12-03 |
| K103202 | PREASSEMBLED SURGICAL WASH SET | Sorin Group Italia S.R.L. | 2010-11-23 |
| K101586 | XTRA AUTOTRANSFUSION SYSTEM | Sorin Group Italia S.R.L. | 2010-10-05 |
| K093535 | AUTOLOG AUTOTRANSFUSION SYSTEM | Medtronic, Inc. | 2010-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327051278 | NA | STRYKER CORPORATION | 2015-09-24 |
| 07613153088806 | NA | STRYKER CORPORATION | 2015-09-23 |
| 07613153088820 | NA | STRYKER CORPORATION | 2015-09-23 |
| 07613154128365 | CBCII Consta Vac | STRYKER CORPORATION | 2015-09-23 |
| 07613154585915 | CBCII ConstaVac | STRYKER CORPORATION | 2015-09-23 |
| 07613327051261 | NA | STRYKER CORPORATION | 2015-09-23 |
| 07613153088752 | NA | STRYKER CORPORATION | 2015-09-23 |
| 08033178105224 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105613 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105231 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105248 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105439 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105446 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105460 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105491 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105569 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105583 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105590 | AUTOTRANSFUSION ACCESSORIES | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105217 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105200 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105187 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105163 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105149 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105088 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105071 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105057 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105040 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105033 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105026 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |
| 08033178105019 | PREASSEMBLED SURGICAL WASH SET | SORIN GROUP ITALIA SRL | 2015-07-15 |