NRY · Catheter, Thrombus Retriever

Cardiovascular · 21 CFR 870.1250 · Class 2

Overview

Product CodeNRY
Device NameCatheter, Thrombus Retriever
Regulation21 CFR 870.1250
Device ClassClass 2
Review PanelCardiovascular

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Classification Rationale

Class II (performance standards).

Recent Cleared Devices (20 of 106)

Showing 20 most recent of 106 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K253590Millipede SystemPerfuze, Ltd.Mar 16, 2026SESE
K253062Tigertriever 25 Revascularization DeviceRapid Medical , Ltd.Mar 12, 2026SESE
K251357Esperance pHLO Aspiration SystemPhenox, Ltd.Jan 15, 2026SESE
K251006NeVasc Aspiration SystemVesalio, Inc.Nov 10, 2025SESE
K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.Oct 30, 2025SESE
K251603Tigertriever 17 Ultra Revascularization DeviceRapid Medical , Ltd.Oct 6, 2025SESE
K251789EMBOTRAP III Revascularization DeviceNeuravi LimitedSep 25, 2025SESE
K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.Aug 29, 2025SESE
K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.Aug 22, 2025SESE
K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLCJun 3, 2025SESE
K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingImperative Care, Inc.May 28, 2025SESE
K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetRoute 92 Medical, Inc.May 19, 2025SESE
K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLCApr 30, 2025SESE
K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLCApr 28, 2025SESE
K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.Feb 26, 2025SESE
K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLCFeb 24, 2025SESE
K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.Feb 13, 2025SESE
K242672Zoom SystemImperative Care, Inc.Jan 14, 2025SESE
K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 NeurovascularOct 29, 2024SESE
K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing SetCerenovus, Inc.Oct 16, 2024SESE

Top Applicants

Innolitics

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