Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
FDA 510(k) clearance K221722 · decided 2022-11-15
Clearance details
- K-number
- K221722
- Device name
- Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- Applicant
- Haemonetics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-06-14
- Decision date
- 2022-11-15
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- CAC
- Device class
- 2
- Regulation number
- 868.5830
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| XTRA Collection sets; XTRA Sequestration set X (K241236) | Sorin Group Italia S.R.L. | 2024-08-16 |
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| XTRA Autotransfusion System (with XTRA Bowl sets) (K240584) | Sorin Group Italia S.R.L. | 2024-04-29 |
| FlowSaver Blood Return System (80-101) (K231782) | Inari Medical, Inc. | 2023-07-14 |
| FlowSaver Blood Return System (K221483) | Inari Medical, Inc. | 2023-02-17 |
| Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (K201305) | Atrium Medical Corporation | 2021-09-03 |
| Hemafuse System (K210862) | Sisu Global Health | 2021-07-29 |
| FlowSaver Blood Filter (K210176) | Inari Medical | 2021-07-22 |
| CATSmart, Automated Blood Processing Autotransfusion System (K210089) | Fresenius Kabi AG | 2021-02-11 |
| ProCell Surgical Sponge-Blood Recovery Unit (K193361) | Procell Surgical, Inc. | 2020-06-01 |
| CATSmart (K192368) | Fresenius Kabi AG | 2019-09-27 |
| CATSmart (K180831) | Fresenius Kabi AG | 2018-12-10 |
Recalls involving this device
No recalls on record reference this clearance.