APRO 35 Swift Catheter and Alembic Aspiration Tubing
FDA 510(k) K262391 · Alembic, LLC
510(k) numberK262391
Submission
- Device name
- APRO 35 Swift Catheter and Alembic Aspiration Tubing
- Applicant
- Alembic, LLC
Mountain View, CA, US - Received
- July 14, 2026
- Decision date
- August 12, 2026
- 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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| 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 |
| 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 |
| K251357 | Esperance pHLO Aspiration SystemNRY · Traditional | Phenox, Ltd. | 01/15/2026SE |
More from Phenox, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262392 | APRO 35 Swift CatheterDQY · Special | 08/12/2026SE |
| K251014 | APRO 45 CatheterDQY · Special | 05/01/2025SE |
| K251015 | APRO 45 Catheter and Alembic Aspiration TubingNRY · Special | 04/30/2025SE |
| K250962 | APRO 55 Intermediate CatheterDQY · Special | 04/29/2025SE |
| K250958 | APRO 55 Swift Catheter and Alembic Aspiration TubingNRY · Special | 04/28/2025SE |
| K243287 | APRO 70 Swift Catheter and Alembic Aspiration TubingNRY · Traditional | 02/24/2025SE |
| K243297 | APRO 70 Swift CatheterQJP · Special | 01/14/2025SE |
| K234115 | APRO 55 CatheterDQY · Traditional | 03/15/2024SE |
| K232971 | APRO 55 Catheter and Alembic Aspiration TubingNRY · Traditional | 02/29/2024SE |
| K230695 | APRO 70 Catheter and Alembic Aspiration TubingNRY · Special | 04/10/2023SE |
Questions and answers
When was APRO 35 Swift Catheter and Alembic Aspiration Tubing cleared by the FDA?
APRO 35 Swift Catheter and Alembic Aspiration Tubing (K262391) received a 510(k) decision of Substantially Equivalent on August 12, 2026, 29 days after the submission was received.
What is the product code of K262391?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.