Tigertriever 13 Ultra Revascularization Device
FDA 510(k) K260617 · Rapid Medical Ltd.
510(k) numberK260617
Submission
- Device name
- Tigertriever 13 Ultra Revascularization Device
- Applicant
- Rapid Medical Ltd.
Yokneam, IL - Received
- February 25, 2026
- Decision date
- August 28, 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.
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| K254276 | Lynx Aspiration Catheter SystemNRY · Traditional | QApel Medical, Inc. | 05/07/2026SE |
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More from Phenox, Ltd.
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|---|---|---|
| K254006 | Drivewire 35 GuidewireMOF · Traditional | 07/17/2026SE |
| K253062 | Tigertriever 25 Revascularization DeviceNRY · Traditional | 03/12/2026SE |
| K251603 | Tigertriever 17 Ultra Revascularization DeviceNRY · Traditional | 10/06/2025SE |
| K233791 | Drivewire 24 GuidewireMOF · Traditional | 07/11/2024SE |
| K230429 | Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device…NRY · Special | 04/17/2023SE |
| K220808 | Tigertriever 13 Revascularization DeviceNRY · Traditional | 07/25/2022SE |
| K203592 | Tigertriever and Tigertriever 17 Revascularization DevceNRY · Traditional | 03/23/2021SE |
| K200374 | Columbus GuidewireMOF · Traditional | 12/14/2020SE |
Questions and answers
When was Tigertriever 13 Ultra Revascularization Device cleared by the FDA?
Tigertriever 13 Ultra Revascularization Device (K260617) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 184 days after the submission was received.
What is the product code of K260617?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.