CAC — Apparatus, Autotransfusion Class II
FDA Device Classification
Classification Details
- Product Code
- CAC
- Device Class
- Class II
- Regulation Number
- 868.5830
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K241236 | sorin group italia | XTRA Collection sets; XTRA Sequestration set X | August 16, 2024 |
| K240426 | inquis medical | Aventus Clot Management System | May 14, 2024 |
| K240584 | sorin group italia | XTRA Autotransfusion System (with XTRA Bowl sets) | April 29, 2024 |
| K231782 | inari medical | FlowSaver Blood Return System (80-101) | July 14, 2023 |
| K221483 | inari medical | FlowSaver Blood Return System | February 17, 2023 |
| K221722 | haemonetics corporation | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | November 15, 2022 |
| K201305 | atrium medical corporation | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc | September 3, 2021 |
| K210862 | sisu global health | Hemafuse System | July 29, 2021 |
| K210176 | inari medical | FlowSaver Blood Filter | July 22, 2021 |
| K210089 | fresenius kabi | CATSmart, Automated Blood Processing Autotransfusion System | February 11, 2021 |
| K193361 | procell surgical | ProCell Surgical Sponge-Blood Recovery Unit | June 1, 2020 |
| K192368 | fresenius kabi | CATSmart | September 27, 2019 |
| K180831 | fresenius kabi | CATSmart | December 10, 2018 |
| K181954 | medtronic perfusion systems | autoLog IQ Autotransfusion System | August 22, 2018 |
| K162423 | haemonetics corporation | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | January 3, 2017 |
| K160735 | fresenius kabi | CATSmart | September 16, 2016 |
| K160197 | haemonetics corporation | Haemonetics Cell Saver Elite Autotransfusion System | May 24, 2016 |
| K140205 | teleflexmedical | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | October 23, 2014 |
| K140197 | teleflexmedical | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | October 21, 2014 |
| K131553 | sorin group deutschland | XTRA | March 21, 2014 |