KRA — Catheter, Continuous Flush Class II
FDA product code KRA covers "Catheter, Continuous Flush", a Class II medical device regulated under 21 CFR 870.1210. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRA
- Device Class
- Class II
- Regulation Number
- 870.1210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261610 | instylla | Verge Microcatheter | June 11, 2026 |
| K260771 | boston scientific corporation | TruSelect 2.6 Microcatheter | May 15, 2026 |
| K250794 | invera medical | InVera Infusion Device | March 12, 2026 |
| K243534 | suzhou zenith vascular scitech limited | Micro Catheter | July 30, 2025 |
| K231821 | transit scientific | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E2 | November 29, 2023 |
| K231279 | ablative solutions | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3- | July 5, 2023 |
| K231148 | vvt medical | ScleroSafe 150 mm, ScleroSafe 350 mm | June 20, 2023 |
| K230957 | trisalus life sciences | TriSalus TriNav® LV Infusion System | May 2, 2023 |
| K223139 | wallaby medical | Wallaby 017 Micro Catheter | April 25, 2023 |
| K223176 | argon medical devices | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Pl | April 10, 2023 |
| K230636 | merit medical system | Maestro Microcatheter | March 30, 2023 |
| K222679 | vascupatent medical (shenzhen) co | Vericor Support Catheter | November 7, 2022 |
| K213435 | balt usa | MAGIC Flow-Dependent Microcatheter | July 19, 2022 |
| K213442 | smartwise sweden | Extroducer Infusion Catheter System | June 10, 2022 |
| K214025 | medos international sarl | PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter | April 12, 2022 |
| K212719 | suzhou hengrui hongyuan medical co | Micro Catheter and Guidewire System | April 11, 2022 |
| K211110 | agile devices | Agile Devices Angler Steerable, Deflectable Microcatheter | January 7, 2022 |
| K210838 | medos international sarl | PROWLER SELECT PLUS; PROWLER EX | August 25, 2021 |
| K210339 | mercator medsystems | Bullfrog Micro-Infusion Device | August 2, 2021 |
| K211525 | merit medical systems | SwiftNINJA Steerable Microcatheter | July 16, 2021 |