510(k) K221722
- Device
- Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- Applicant
- Haemonetics Corporation
- 510(k) number
- K221722
- Product code
- CAC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-15
- Date received
- 2022-06-14
- Regulation
- 868.5830
- Classification name
- Apparatus, Autotransfusion
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ergang Alexis
- Address
- 125 Summer St. Boston MA US 02110 02110
FDA Registration Numbers#
- 2184009
- 9617787
- 1220477
- 3010273872
- 3005012805
- 3010413216
- 8043817
- 1718850
- 1526534
- 9680841
- 3016994551
- 3004593495
- 2528981
- 3004548776
- 3011554160
- 3019807891
- 1424263
- 3010291427
- 9680143
- 1219343
- 3015219237
- 2032112
- 3004634229
- 1724474
- 3010009632
- 2029275
- 3011137372
- 3031823122
- 1064858
- 9617601
- 3011773324
- 3010041511
- 1928237
- 3008810357
- 9612051
- 3020347218
- 9681630
- 3011175548
- 3011270181
- 3004365956
- 1836518
- 8022032
- 3006654680
- 9615908
- 3004142400
- 2011171
- 3004111573
- 3009380063
- 3007923088
- 3010220595
- 9611109
- 9680425
- 2029015
Source Documents#
Other 510(k) Records For Product Code CAC#
| 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 |
| 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 |