p17 XR Microcatheter
FDA 510(k) K254071 · Wallaby Medical
510(k) numberK254071
Submission
- Device name
- p17 XR Microcatheter
- Applicant
- Wallaby Medical
Laguna Hills, CA, US - Received
- December 18, 2025
- Decision date
- August 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Other 510(k)s with product code QJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| K253901 | Millipede88 Access CatheterQJP · Traditional | Perfuze, Ltd. | 07/09/2026SE |
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | Stryker Neurovascular | 07/01/2026SE |
| K261808 | ISAAC Neurovascular Navigation CatheterQJP · Special | Microvention Inc. d/b/a Terumo Neuro | 06/30/2026SE |
| K261549 | BOBBY Balloon Guide CatheterQJP · Special | MicroVention, Inc., d/b/a Terumo Neuro | 06/09/2026SE |
| K253359 | Zenith Distal Access Long SheathQJP · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/22/2026SE |
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | Asahi Intecc Co., Ltd. | 05/11/2026SE |
| K254046 | BosCATH Support CatheterQJP · Traditional | Sonorous NV, Inc. | 04/21/2026SE |
More from Sonorous NV, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | 04/25/2023SE |
| 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 p17 XR Microcatheter cleared by the FDA?
p17 XR Microcatheter (K254071) received a 510(k) decision of Substantially Equivalent on August 18, 2026, 243 days after the submission was received.
What is the product code of K254071?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.