Millipede88 Access Catheter
FDA 510(k) K253901 · Perfuze, Ltd.
510(k) numberK253901
Submission
- Device name
- Millipede88 Access Catheter
- Applicant
- Perfuze, Ltd.
Galway, IE - Received
- December 5, 2025
- Decision date
- July 9, 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 |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| 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 |
|---|---|---|
| K262399 | Millipede SystemNRY · Special | 08/12/2026SE |
| K253590 | Millipede SystemNRY · Traditional | 03/16/2026SE |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | 08/29/2025SE |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Special | 02/26/2025SE |
| K240711 | Zipline Access CatheterQJP · Traditional | 10/17/2024SE |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration…NRY · Special | 09/20/2024SE |
| K233648 | Millipede 088 Access CatheterQJP · Special | 12/14/2023SE |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetNRY · Traditional | 10/18/2023SE |
| K231802 | Millipede 088 Access CatheterQJP · Special | 09/19/2023SE |
| K214048 | Millipede 088 Access CatheterQJP · Traditional | 09/20/2022SE |
Questions and answers
When was Millipede88 Access Catheter cleared by the FDA?
Millipede88 Access Catheter (K253901) received a 510(k) decision of Substantially Equivalent on July 9, 2026, 216 days after the submission was received.
What is the product code of K253901?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.