Zoom System (Zoom 4S Catheter)
FDA 510(k) K252046 · Imperative Care, Inc.
510(k) numberK252046
Submission
- Device name
- Zoom System (Zoom 4S Catheter)
- Applicant
- Imperative Care, Inc.
Campbell, CA, US - Received
- June 30, 2025
- Decision date
- October 30, 2025
- 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.
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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 |
|---|---|---|
| K261176 | Zoom 4S CatheterQJP · Traditional | 08/28/2026SE |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy SystemQEW · Traditional | 08/28/2025SE |
| K244061 | X-Wire GuidewireMOF · Traditional | 08/26/2025SE |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY · Traditional | 05/28/2025SE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | 05/14/2025SE |
| K242672 | Zoom SystemNRY · Traditional | 01/14/2025SE |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Traditional | 06/06/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | 04/02/2024SE |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Special | 05/22/2023SE |
| K220807 | Imperative Care Radial 088 Access SystemQJP · Traditional | 05/17/2022SE |
Questions and answers
When was Zoom System (Zoom 4S Catheter) cleared by the FDA?
Zoom System (Zoom 4S Catheter) (K252046) received a 510(k) decision of Substantially Equivalent on October 30, 2025, 122 days after the submission was received.
What is the product code of K252046?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.