Solitaire 2 Revascularization Device
FDA 510(k) K141491 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
510(k) numberK141491
Submission
- Device name
- Solitaire 2 Revascularization Device
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA, US - Received
- June 5, 2014
- Decision date
- October 22, 2014
- 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 |
|---|---|---|
| K241388 | Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…QJP · Special | 01/02/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | 12/02/2024SE |
| K243080 | Riptide Aspiration SystemNRY · Special | 10/29/2024SE |
| K211990 | Rist 071 Radial Access Guide CatheterDQY · Special | 07/27/2021SE |
| K203432 | Axium Detachable Coil; Axium Prime Detachable CoilHCG · Traditional | 07/07/2021SE |
| K203358 | Solitaire X Revascularization DevicePOL · Traditional | 03/01/2021SE |
| K202850 | Concerto Versa, Detachable CoilKRD · Traditional | 02/09/2021SE |
| K193576 | Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device…POL · Traditional | 11/20/2020SE |
| K202318 | Marathon Flow Directed Micro CatheterKRA · Special | 09/14/2020SE |
| K201690 | Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireDQX · Special | 07/21/2020SE |
Questions and answers
When was Solitaire 2 Revascularization Device cleared by the FDA?
Solitaire 2 Revascularization Device (K141491) received a 510(k) decision of Substantially Equivalent on October 22, 2014, 139 days after the submission was received.
What is the product code of K141491?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.