SOFIA EX Intracranial Support Catheter
FDA 510(k) K230775 · MicroVention, Inc.
510(k) numberK230775
Submission
- Device name
- SOFIA EX Intracranial Support Catheter
- Applicant
- MicroVention, Inc.
Aliso Viejo, CA, US - Received
- March 21, 2023
- Decision date
- September 14, 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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|---|---|---|---|
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| 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.
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| K232542 | Wedge XL Delivery CatheterQJP · Traditional | 05/16/2024SE |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)NTE · Traditional | 04/27/2023SE |
| K222115 | ISAAC Neurovascular Navigation CatheterDQY · Traditional | 01/10/2023SE |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)KRD · Traditional | 12/21/2022SE |
| K214024 | SOFIA 88 CatheterDQY · Traditional | 09/12/2022SE |
| K211120 | ERIC Retrieval DeviceNRY · Traditional | 03/31/2022SE |
| K193607 | BOBBY Balloon Guide CatheterDQY · Traditional | 07/21/2020SE |
| K201487 | Traxcess 7 Mini GuidewireMOF · Special | 07/02/2020SE |
| K200547 | Traxcess 14 SELECT GuidewireMOF · Special | 04/16/2020SE |
Questions and answers
When was SOFIA EX Intracranial Support Catheter cleared by the FDA?
SOFIA EX Intracranial Support Catheter (K230775) received a 510(k) decision of Substantially Equivalent on September 14, 2023, 177 days after the submission was received.
What is the product code of K230775?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.