BEUDAMED
    Product Code: NRY FDA class 2 21 CFR 870.1250

    Catheter, Thrombus Retriever

    Cardiovascular

    The Thrombus Retriever Catheter is a cardiovascular device intended to restore blood flow by removing thrombus or clots in patients experiencing ischemic stroke, representing a distinct claim from general-purpose catheters placed in peripheral, coronary, or neurovascular anatomies. It is used in acute intervention to recanalize occluded cerebral vessels. This is an FDA Class 2 device regulated under 21 CFR 870.1250 in the Cardiovascular specialty and reviewed by the Neurology panel, with product code NRY, requiring 510(k) clearance. It is not an implant and does not provide life-sustaining support.

    View on FDA
    510(k)s
    97
    FEI Numbers
    57
    Registration Numbers
    57
    Unique Applicants
    31
    Years Active
    21

    Basic Information

    Product Code
    NRY
    Device Class
    FDA class 2
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 97 510(k) clearances via K numbers.

    K Number Device Name
    K243948 Raptor Aspiration Catheter; Balt Aspiration Tubing Set
    K243047 Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
    K243601 Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
    K251015 APRO 45 Catheter and Alembic Aspiration Tubing
    K250958 APRO 55 Swift Catheter and Alembic Aspiration Tubing
    K250012 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K243287 APRO 70 Swift Catheter and Alembic Aspiration Tubing
    K242104 Penumbra System (Reperfusion Catheter RED 72)
    K242672 Zoom System
    K243080 Riptide Aspiration System
    K241221 CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set
    K240917 Esperance 3+ Aspiration Catheter System
    K242504 Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K234083 Next Generation Aspiration Catheter; Balt Aspiration Tubing Set
    K233329 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
    K232971 APRO 55 Catheter and Alembic Aspiration Tubing
    K233988 Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set
    K232524 Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
    K223913 Socrates Aspiration System
    K222786 072 Aspiration System
    K230429 Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
    K223530 Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
    K230695 APRO 70 Catheter and Alembic Aspiration Tubing
    K221934 CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set
    K223545 APRO 70 Catheter and Alembic Aspiration Tubing
    K222808 Penumbra System (Reperfusion Catheter RED 43)
    K220808 Tigertriever 13 Revascularization Device
    K211120 ERIC Retrieval Device
    K211697 Esperance Aspiration Catheter System
    K212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
    K211654 Penumbra System (Reperfusion Catheter RED 72)
    K211338 EMBOTRAP III Revascularization Device
    K211411 Penumbra System (RED 68 Reperfusion Catheter)
    K211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
    K203440 Penumbra System (Reperfusion Catheter RED 62)
    K210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
    K203592 Tigertriever and Tigertriever 17 Revascularization Devce
    K202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
    K202251 Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)
    K201689 Riptide Aspiration System
    K193380 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set
    K193063 EMBOTRAP III Revascularization Device
    K191946 Penumbra System Penumbra JET 7X
    K190338 046 Zenith Flex
    K191768 AXS Vecta Aspiration System
    K190010 Penumbra System Reperfusion Catheter JET 7
    K190464 Penumbra System 3D Revascularization Device
    K190212 AXS Vecta Aspiration System
    K183043 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
    K183464 AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
    K183185 Riptide Aspiration System (Riptide Large Bore Aspiration System)
    K182101 Riptide Aspiration System (React 71 Catheter)
    K181354 074 Zenith Flex System
    K182522 Penumbra System (Modified 110 Aspiration Tubing)
    K173761 Penumbra System Reperfusion Catheter JET 7
    K180705 Riptide Aspiration System React 68 Catheter
    K180008 Penumbra System
    K173200 SOFIA Plus Aspiration Catheter
    K173452 EmboTrap ll Revascularization Device
    K172167 Zenith Flex System
    K173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
    K172448 Riptide Aspiration System
    K162901 Penumbra 3D Revascularization Device
    K160641 Solitaire Platinum Revascularization Device, 6x40 mm
    K161879 Solitaire Platinum Revascularization Device
    K161640 Penumbra System ACE 68 Reperfusion Catheter
    K161064 Penumbra System ACE 68 Reperfusion Catheter
    K160449 Penumbra System, Penumbra Pump MAX
    K152541 Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
    K153071 Solitaire Platinum Revascularization Device
    K151623 Penumbra System 110 Aspiration Tubing
    K150616 Trevo XP ProVue Retriever (4x30mm)
    K142458 Penumbra System ACE
    K143077 Trevo XP ProVue Retriever (6X25mm)
    K141516 MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
    K141491 SOLITAIRE 2 REVASCULARIZATION DEVICE
    K133317 PENUMBRA SYSTEM / PENUMBRA SYSTEM MAX
    K133464 MODIFIED TREVO PROVUE RETRIEVER
    K132641 MODIFIED TREVO PROVUE RETRIEVER
    K123378 SOLITAIRE 2 REVASCULARIZATION DEVICE
    K122478 MODIFIED TREVO RETRIEVER
    K120961 TREVO RETRIEVER
    K113455 SOLITAIRE FR REVASCULARIZATION DEVICE
    K113163 PENUMBRA SYSTEM MAX
    K093610 MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
    K100769 PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054
    K090752 PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054
    K090085 MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
    K082034 MODIFICATION TO MERCI RETRIEVER
    K081305 MERCI RETRIEVER
    K072718 PENUMBRA SYSTEM
    K071172 MODIFIED MERCI RETRIEVER, MODEL 90060
    K070521 MODIFIED MERCY RETRIEVER, MODEL 90070
    K063774 MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
    K062046 MODIFIED MERCI RETRIEVER, MODEL 90050
    K061059 MODIFIED MERCI RETRIEVER, MODEL 90092
    K033736 MERCI RETRIEVER, MODELS 90065, 90066

    FEI Numbers

    This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.