CAC — Apparatus, Autotransfusion Class II
FDA product code CAC covers "Apparatus, Autotransfusion", a Class II medical device regulated under 21 CFR 868.5830. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |