CAC
- Product code
- CAC
- Device name
- Apparatus, Autotransfusion
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5830
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 195 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241236 | 2024-08-16 | Sorin Group Italia S.R.L. | XTRA Collection sets; XTRA Sequestration set X | |
| K240426 | 2024-05-14 | Inquis Medical | Aventus Clot Management System | |
| K240584 | 2024-04-29 | Sorin Group Italia S.R.L. | XTRA Autotransfusion System (with XTRA Bowl sets) |
Official FDA classification page: CAC
Classification and pathway per current FDA publications. Data from openFDA (CC0).