Tigertriever 13 Revascularization Device
FDA 510(k) K220808 · Rapid Medical Ltd.
510(k) numberK220808
Submission
- Device name
- Tigertriever 13 Revascularization Device
- Applicant
- Rapid Medical Ltd.
Yokneam, IL - Received
- March 18, 2022
- Decision date
- July 25, 2022
- 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 |
|---|---|---|
| K260617 | Tigertriever 13 Ultra Revascularization DeviceNRY · Traditional | 08/28/2026SE |
| 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 |
| 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 Revascularization Device cleared by the FDA?
Tigertriever 13 Revascularization Device (K220808) received a 510(k) decision of Substantially Equivalent on July 25, 2022, 129 days after the submission was received.
What is the product code of K220808?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.