AXS Vecta Aspiration System
FDA 510(k) K190212 · Stryker Neurovascular
510(k) numberK190212
Submission
- Device name
- AXS Vecta Aspiration System
- Applicant
- Stryker Neurovascular
Fremont, CA, US - Received
- February 4, 2019
- Decision date
- April 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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.
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| 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 |
|---|---|---|
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | 07/01/2026SE |
| K253032 | AXS Lift Intracranial Base CatheterQJP · Traditional | 02/11/2026SE |
| K252694 | Target Detachable CoilHCG · Traditional | 12/11/2025SE |
| K251832 | InZone IST Detachment System; IZDS Connecting CableHCG · Special | 10/17/2025SE |
| K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27…QJP · Special | 03/21/2025SE |
| K243593 | AXS Lift Intracranial Base CatheterQJP · Traditional | 02/18/2025SE |
| K241768 | Broadway 8 CatheterQJP · Traditional | 12/19/2024SE |
| K241637 | Echo Intracranial Base CatheterQJP · Traditional | 12/19/2024SE |
| K223305 | Trevo NXT ProVue RetrieverPOL · Traditional | 03/29/2023SE |
| K222533 | Target Tetra Detachable CoilsHCG · Traditional | 12/14/2022SE |
Questions and answers
When was AXS Vecta Aspiration System cleared by the FDA?
AXS Vecta Aspiration System (K190212) received a 510(k) decision of Substantially Equivalent on April 24, 2019, 79 days after the submission was received.
What is the product code of K190212?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.