Esperance Aspiration Catheter System
FDA 510(k) K211697 · Wallaby Medical
510(k) numberK211697
Submission
- Device name
- Esperance Aspiration Catheter System
- Applicant
- Wallaby Medical
Laguna Hills, CA, US - Received
- June 3, 2021
- Decision date
- November 16, 2021
- 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 |
|---|---|---|
| K254071 | p17 XR MicrocatheterQJP · Traditional | 08/18/2026SE |
| K240917 | Esperance 3+ Aspiration Catheter SystemNRY · Traditional | 10/01/2024SE |
| K231056 | Esperance Distal Access CatheterQJP · Traditional | 03/08/2024SE |
| K232437 | Paragon 8F Balloon Guide CatheterDQY · Traditional | 10/13/2023SE |
| K223139 | Wallaby 017 Micro CatheterKRA · Traditional | 04/25/2023SE |
| K222603 | 6F Wallaby Long SheathDQY · Traditional | 03/02/2023SE |
| K173711 | Wallaby Avenir Coil SystemHCG · Traditional | 05/04/2018SE |
Questions and answers
When was Esperance Aspiration Catheter System cleared by the FDA?
Esperance Aspiration Catheter System (K211697) received a 510(k) decision of Substantially Equivalent on November 16, 2021, 166 days after the submission was received.
What is the product code of K211697?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.