Citrated: K, KH, RTH, FFH— 510(k) K232018
Substantially EquivalentHaemonetics Corporation
FDA 510(k) clearance K232018 for Citrated: K, KH, RTH, FFH, Substantially Equivalent on 2024-03-29. Applicant: Haemonetics Corporation. Device class: 2.
Clearance details
- Applicant
- Haemonetics Corporation
- Product code
- Code JPA
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code JPA
view allMore clearances from Haemonetics Corporation
view all- 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
- K162423 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System
- K160197 — Haemonetics Cell Saver Elite Autotransfusion System
Adverse events under product code JPA
product code JPA- Death
- 6
- Total
- 6
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.