Haemonetics Cell Saver Elite Autotransfusion System— 510(k) K160197
Substantially EquivalentHaemonetics Corporation
FDA 510(k) clearance K160197 for Haemonetics Cell Saver Elite Autotransfusion System, Substantially Equivalent on 2016-05-24. Applicant: Haemonetics Corporation. Device class: 2.
Clearance details
- Applicant
- Haemonetics Corporation
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Braintree, MA, US
Recent devices under product code CAC
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view all- K243858 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
- K232018 — Citrated: K, KH, RTH, FFH
- K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)
- K183160 — TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
- K160502 — TEG 6s Hemostasis System
Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.