Plato 17 Microcatheter
FDA 510(k) K223560 · Scientia Vascular, Inc.
510(k) numberK223560
Submission
- Device name
- Plato 17 Microcatheter
- Applicant
- Scientia Vascular, Inc.
West Valley City, UT, US - Received
- November 28, 2022
- Decision date
- August 21, 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
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 |
| 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 |
|---|---|---|
| K260223 | Aristotle Mini GuidewireMOF · Traditional | 08/06/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | 07/16/2026SE |
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Traditional | 04/29/2026SE |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…MOF · Special | 04/01/2025SE |
| K242301 | Socrates 38 CatheterQJP · Traditional | 12/04/2024SE |
| K223913 | Socrates Aspiration SystemNRY · Traditional | 09/20/2023SE |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 GuidewireMOF · Special | 08/01/2023SE |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…MOF · Special | 03/10/2023SE |
| K222437 | Aristotle Colossus GuidewireMOF · Traditional | 01/26/2023SE |
| K210601 | Plato 17 MicrocatheterDQY · Traditional | 04/28/2021SE |
Questions and answers
When was Plato 17 Microcatheter cleared by the FDA?
Plato 17 Microcatheter (K223560) received a 510(k) decision of Substantially Equivalent on August 21, 2023, 266 days after the submission was received.
What is the product code of K223560?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.