Socrates Aspiration System
FDA 510(k) K223913 · Scientia Vascular, Inc.
510(k) numberK223913
Submission
- Device name
- Socrates Aspiration System
- Applicant
- Scientia Vascular, Inc.
West Valley City, UT, US - Received
- December 29, 2022
- Decision date
- September 20, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Other 510(k)s with product code NRY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 08/28/2026SE |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setNRY · Special | CERENOVUS, Inc. | 08/13/2026SE |
| K262399 | Millipede SystemNRY · Special | Perfuze, Ltd. | 08/12/2026SE |
| K262391 | APRO 35 Swift Catheter and Alembic Aspiration TubingNRY · Special | Alembic, LLC | 08/12/2026SE |
| K260002 | Socrates Aspiration System (Socrates 70 Aspiration Catheter)NRY · Traditional | Scientia Vascular, Inc. | 07/16/2026SE |
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | Penumbra, Inc. | 06/10/2026SE |
| K252707 | Zenith Aspiration Catheter; Disposable Aspiration Tubing SetNRY · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/20/2026SE |
| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
| K253590 | Millipede SystemNRY · Traditional | Perfuze, Ltd. | 03/16/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | Rapid Medical Ltd. | 03/12/2026SE |
More from Rapid Medical 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 |
| K223560 | Plato 17 MicrocatheterQJP · Traditional | 08/21/2023SE |
| 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 Socrates Aspiration System cleared by the FDA?
Socrates Aspiration System (K223913) received a 510(k) decision of Substantially Equivalent on September 20, 2023, 265 days after the submission was received.
What is the product code of K223913?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.