FDA product code NRY: Catheter, Thrombus Retriever
NRY is the FDA product code for catheter, thrombus retriever. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Neurology panel. FDA has cleared 115 510(k) submissions under NRY, 46 in the last five years, from 27 different applicants. The average 510(k) review took 131 days (median 119); 139 days on average over the last three years. FDA has posted 26 recalls for NRY devices, 6 initiated in the last five years.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Thrombus Retriever |
| Device class | Class II |
| Regulation | 21 CFR 870.1250 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for NRY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 227 |
| 2018 | 11 | 149 |
| 2019 | 7 | 108 |
| 2020 | 6 | 130 |
| 2021 | 9 | 83 |
| 2022 | 3 | 191 |
| 2023 | 8 | 154 |
| 2024 | 8 | 125 |
| 2025 | 15 | 123 |
| 2026 | 12 | 170 |
Compare with all 510(k) review times · Search every NRY clearance
Top NRY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Penumbra, Inc. | 25 | 2026-06-10 |
| Concentric Medical, Inc. | 16 | 2015-06-12 |
| Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 11 | 2024-10-29 |
| Alembic, LLC | 7 | 2026-08-12 |
| Imperative Care, Inc. | 7 | 2025-10-30 |
22 more applicants have NRY clearances. See the full list in Caduvo.
Most recent NRY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261089 | Maduro Medical, Inc. | Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit | 2026-09-14 | 166 |
| K260617 | Rapid Medical Ltd. | Tigertriever 13 Ultra Revascularization Device | 2026-08-28 | 184 |
| K262398 | CERENOVUS, Inc. | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | 2026-08-13 | 30 |
| K262391 | Alembic, LLC | APRO 35 Swift Catheter and Alembic Aspiration Tubing | 2026-08-12 | 29 |
| K262399 | Perfuze, Ltd. | Millipede System | 2026-08-12 | 29 |
Recalls for NRY devices
26 product recalls in 17 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2026-06-03.
| Year | Recalls |
|---|---|
| 2017 | 9 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 4 |
| 2021 | 1 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NRY?
NRY is the FDA product code for catheter, thrombus retriever. It is a Class II device, regulated under 21 CFR 870.1250 and reviewed by the Neurology panel.
What device class is NRY?
Class II, regulation 21 CFR 870.1250. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRY?
Across 115 cleared submissions the average was 131 days from receipt to decision (median 119).
Which companies have the most NRY clearances?
Penumbra, Inc. (25); Concentric Medical, Inc. (16); Micro Therapeutics, Inc. d/b/a ev3 Neurovascular (11); Alembic, LLC (7); Imperative Care, Inc. (7).
Have NRY devices been recalled?
Yes: 26 product recalls across 17 recall events; the most recent began 2026-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NRY
- Run a recall and safety report across every NRY manufacturer
- Watch product code NRY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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