NRY

Catheter, Thrombus Retriever

Product code
NRY
Device name
Catheter, Thrombus Retriever
Device class
Class 2
21 CFR
21 CFR 870.1250
Medical specialty
Cardiovascular
Marketing pathway
510(K)
510(k) clearances (last 3 years)
36
Summaries archived here
34 (direct download)
510(k) clearances (all years, FDA)
114 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (36)

Last three years. Most recent: 2026-08-28.

NumberDecision dateApplicantDevice nameSummary
K2606172026-08-28Rapid Medical Ltd.Tigertriever 13 Ultra Revascularization DevicePDF
K2623982026-08-13CERENOVUS, Inc.CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspira…PDF
K2623992026-08-12Perfuze, Ltd.Millipede SystemPDF
K2623912026-08-12Alembic, LLCAPRO 35 Swift Catheter and Alembic Aspiration TubingFDA
K2600022026-07-16Scientia Vascular, Inc.Socrates Aspiration System (Socrates 70 Aspiration C…PDF
K2506902026-06-10Penumbra, Inc.Penumbra System (Thunderbolt Aspiration Tubing)PDF
K2527072026-05-20Suzhou Zenith Vascular SciTech LimitedZenith Aspiration Catheter; Disposable Aspiration Tu…PDF
K2542762026-05-07Q’Apel Medical, Inc.Lynx Aspiration Catheter SystemPDF
K2535902026-03-16Perfuze, Ltd.Millipede SystemPDF
K2530622026-03-12Rapid Medical Ltd.Tigertriever 25 Revascularization DevicePDF
K2513572026-01-15Phenox, Ltd.Esperance pHLO Aspiration SystemPDF
K2510062025-11-10Vesalio, Inc.NeVasc Aspiration SystemPDF
K2520462025-10-30Imperative Care, Inc.Zoom System (Zoom 4S Catheter)PDF
K2516032025-10-06Rapid Medical Ltd.Tigertriever 17 Ultra Revascularization DevicePDF
K2517892025-09-25Neuravi LimitedEMBOTRAP III Revascularization DevicePDF
K2523922025-08-29Perfuze, Ltd.Millipede70 Aspiration Catheter; Perfuze Aspiration …PDF
K2518282025-08-22Cerenovus, Inc.CEREGLIDE 71 Catheter System; Cerenovus Aspiration T…PDF
K2439482025-06-03Balt USA, LLCRaptor Aspiration Catheter; Balt Aspiration Tubing S…PDF
K2430472025-05-28Imperative Care, Inc.Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD A…PDF
K2436012025-05-19Route 92 Medical, Inc.Route 92 Medical HiPoint Reperfusion System and Aspi…PDF
K2510152025-04-30Alembic, LLCAPRO 45 Catheter and Alembic Aspiration TubingPDF
K2509582025-04-28Alembic, LLCAPRO 55 Swift Catheter and Alembic Aspiration TubingPDF
K2500122025-02-26Perfuze, Ltd.Millipede 070 Aspiration Catheter; Perfuze Aspiratio…PDF
K2432872025-02-24Alembic, LLCAPRO 70 Swift Catheter and Alembic Aspiration TubingPDF
K2421042025-02-13Penumbra, Inc.Penumbra System (Reperfusion Catheter RED 72)PDF
K2426722025-01-14Imperative Care, Inc.Zoom SystemPDF
K2430802024-10-29Micro Therapeutics, Inc. d/b/a ev3 Neu…Riptide Aspiration SystemPDF
K2412212024-10-16Cerenovus, Inc.CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Int…PDF
K2409172024-10-01Wallaby MedicalEsperance 3+ Aspiration Catheter SystemPDF
K2425042024-09-20Perfuze, Ltd.Millipede 088 Access Catheter; Millipede 070 Aspirat…FDA
K2340832024-07-02Balt USA, LLCNext Generation Aspiration Catheter; Balt Aspiration…PDF
K2333292024-04-23Route 92 Medical, Inc.Route 92 Medical Full Length 054 Reperfusion System …PDF
K2329712024-02-29Alembic, LLCAPRO 55 Catheter and Alembic Aspiration TubingPDF
K2339882024-01-17Cerenovus, Inc.Cerenovus Large Bore Catheter; Cerenovus Aspiration …PDF
K2325242023-10-18Perfuze, Ltd.Millipede 070 Aspiration Catheter; Perfuze Aspiratio…PDF
K2239132023-09-20Scientia Vascular, Inc.Socrates Aspiration SystemPDF

34 summaries are archived here for direct download.

Official FDA classification page: NRY
Classification and pathway per current FDA publications. Data from openFDA (CC0).