SelectFlex Neurovascular Access System Family
FDA 510(k) K230322 · Q'Apel Medical, Inc.
510(k) numberK230322
Submission
- Device name
- SelectFlex Neurovascular Access System Family
- Applicant
- Q'Apel Medical, Inc.
Fremont, CA, US - Received
- February 6, 2023
- Decision date
- June 22, 2023
- 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
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|---|---|---|---|
| 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 |
| 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 |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | 05/07/2026SE |
| K240746 | Neurovascular Access System FamilyQJP · Traditional | 11/20/2024SE |
| K222786 | 072 Aspiration SystemNRY · Traditional | 08/25/2023SE |
| K211893 | SelectFlex Neurovascular Access System FamilyQJP · Special | 08/05/2021SE |
| K192525 | 087 Balloon Guide Catheter SystemDQY · Traditional | 10/31/2019SE |
| K191664 | SelectFlex 072 Neurovascular Access SystemDQY · Special | 08/30/2019SE |
Questions and answers
When was SelectFlex Neurovascular Access System Family cleared by the FDA?
SelectFlex Neurovascular Access System Family (K230322) received a 510(k) decision of Substantially Equivalent on June 22, 2023, 136 days after the submission was received.
What is the product code of K230322?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.