KRJ
- Product code
- KRJ
- Device name
- Filter, Prebypass, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4280
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 24 (all years; only the last 3 years are listed here)
Official FDA classification page: KRJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).