Penumbra System (Thunderbolt Aspiration Tubing)
FDA 510(k) K250690 · Penumbra, Inc.
510(k) numberK250690
Submission
- Device name
- Penumbra System (Thunderbolt Aspiration Tubing)
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- March 7, 2025
- Decision date
- June 10, 2026
- 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 |
| 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 |
|---|---|---|
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | 04/24/2026SE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | 02/05/2026SE |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…QEW · Traditional | 10/16/2025SE |
| K250079 | Ruby XL SystemKRD · Traditional | 03/14/2025SE |
| K242104 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | 02/13/2025SE |
| K242033 | Access25 Delivery MicrocatheterQJP · Traditional | 12/11/2024SE |
| K242520 | Element Vascular Access SystemDYB · Traditional | 11/20/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | 09/03/2024SE |
| K241399 | Indigo® Lightning Flash Aspiration System Select + CatheterQEW · Special | 06/10/2024SE |
Questions and answers
When was Penumbra System (Thunderbolt Aspiration Tubing) cleared by the FDA?
Penumbra System (Thunderbolt Aspiration Tubing) (K250690) received a 510(k) decision of Substantially Equivalent on June 10, 2026, 460 days after the submission was received.
What is the product code of K250690?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.