Wallaby 017 Micro Catheter
FDA 510(k) K223139 · Wallaby Medical
510(k) numberK223139
Submission
- Device name
- Wallaby 017 Micro Catheter
- Applicant
- Wallaby Medical
Laguna Hills, CA, US - Received
- October 4, 2022
- Decision date
- April 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
Other 510(k)s with product code KRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254051 | Extroducer Infusion Catheter SystemKRA · Traditional | SmartWise Sweden AB | 09/11/2026SE |
| K261610 | Verge MicrocatheterKRA · Special | Instylla, Inc. | 06/11/2026SE |
| K260771 | TruSelect 2.6 MicrocatheterKRA · Special | Boston Scientific Corporation | 05/15/2026SE |
| K250794 | InVera Infusion DeviceKRA · Traditional | Invera Medical | 03/12/2026SE |
| K243534 | Micro CatheterKRA · Traditional | Suzhou Zenith Vascular SciTech Limited | 07/30/2025SE |
| K231821 | XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S…KRA · Traditional | Transit Scientific, LLC | 11/29/2023SE |
| K231279 | Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmKRA · Traditional | Ablative Solutions, Inc. | 07/05/2023SE |
| K231148 | ScleroSafe 150 mm, ScleroSafe 350 mmKRA · Traditional | Vvt Medical , Ltd. | 06/20/2023SE |
| K230957 | TriSalus TriNav® LV Infusion SystemKRA · Traditional | Trisalus Life Sciences | 05/02/2023SE |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus…KRA · Special | Argon Medical Devices, Inc. | 04/10/2023SE |
More from Argon Medical Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K254071 | p17 XR MicrocatheterQJP · Traditional | 08/18/2026SE |
| K240917 | Esperance 3+ Aspiration Catheter SystemNRY · Traditional | 10/01/2024SE |
| K231056 | Esperance Distal Access CatheterQJP · Traditional | 03/08/2024SE |
| K232437 | Paragon 8F Balloon Guide CatheterDQY · Traditional | 10/13/2023SE |
| K222603 | 6F Wallaby Long SheathDQY · Traditional | 03/02/2023SE |
| K211697 | Esperance Aspiration Catheter SystemNRY · Traditional | 11/16/2021SE |
| K173711 | Wallaby Avenir Coil SystemHCG · Traditional | 05/04/2018SE |
Questions and answers
When was Wallaby 017 Micro Catheter cleared by the FDA?
Wallaby 017 Micro Catheter (K223139) received a 510(k) decision of Substantially Equivalent on April 25, 2023, 203 days after the submission was received.
What is the product code of K223139?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.