KRA
- Product code
- KRA
- Device name
- Catheter, Continuous Flush
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1210
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 175 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261610 | 2026-06-11 | Instylla, Inc. | Verge Microcatheter | |
| K260771 | 2026-05-15 | Boston Scientific Corporation | TruSelect 2.6 Microcatheter | |
| K250794 | 2026-03-12 | Invera Medical | InVera Infusion Device | |
| K243534 | 2025-07-30 | Suzhou Zenith Vascular SciTech Limited | Micro Catheter | |
| K231821 | 2023-11-29 | Transit Scientific, LLC | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130… | FDA |
Official FDA classification page: KRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).