CAC · Apparatus, Autotransfusion
Anesthesiology · 21 CFR 868.5830 · Class 2
Overview
| Product Code | CAC |
|---|---|
| Device Name | Apparatus, Autotransfusion |
| Regulation | 21 CFR 868.5830 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| Life-Sustaining | Yes |
Identification
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 195)
Showing 20 most recent of 195 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | Aug 16, 2024 | SESE |
| K240426 | Aventus Clot Management System | Inquis Medical | May 14, 2024 | SESE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | Apr 29, 2024 | SESE |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | Jul 14, 2023 | SESE |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | Feb 17, 2023 | SESE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | Nov 15, 2022 | SESE |
| 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 | Sep 3, 2021 | SESE |
| K210862 | Hemafuse System | Sisu Global Health | Jul 29, 2021 | SESE |
| K210176 | FlowSaver Blood Filter | Inari Medical | Jul 22, 2021 | SESE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG | Feb 11, 2021 | SESE |
| K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | Jun 1, 2020 | SESE |
| K192368 | CATSmart | Fresenius Kabi AG | Sep 27, 2019 | SESE |
| K180831 | CATSmart | Fresenius Kabi AG | Dec 10, 2018 | SESE |
| K181954 | autoLog IQ Autotransfusion System | Medtronic Perfusion Systems | Aug 22, 2018 | SESE |
| K162423 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System | Haemonetics Corporation | Jan 3, 2017 | SESE |
| K160735 | CATSmart | Fresenius Kabi AG | Sep 16, 2016 | SESE |
| K160197 | Haemonetics Cell Saver Elite Autotransfusion System | Haemonetics Corporation | May 24, 2016 | SESE |
| K140205 | PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | Oct 23, 2014 | SESE |
| K140197 | PLEUR-EVAC PLUS CONTINUOUS REINFUSION AND AUTOTRANSFUSION SYSTEM | Teleflexmedical, Inc. | Oct 21, 2014 | SESE |
| K131553 | XTRA | Sorin Group Deutschland GmbH | Mar 21, 2014 | SESE |
Top Applicants
- Haemonetics Corp. — 15 clearances
- Boehringer Laboratories — 12 clearances
- Deknatel, Inc. — 11 clearances
- Shiley, Inc. — 11 clearances
- Atrium Medical Corp. — 9 clearances
