BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PENUMBRA, INC.

    Reg #: 3005168196 · FEI: 3005168196 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    76
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    PENUMBRA, INC.
    Registration Number
    3005168196
    FEI Number
    3005168196
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    One Penumbra Place
    City
    Alameda
    State
    CA
    ZIP
    94502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202251

    Owner / Operator

    Firm Name
    PENUMBRA, INC.
    Operator Number
    9072336
    Address
    One Penumbra Place
    City
    Alameda
    State
    CA
    Postal Code
    94502
    Country
    US

    Products

    Device Name Product Code
    Catheter, Thrombus Retriever NRY
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Pump, Portable, Aspiration (Manual Or Powered) BTA
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Coronary Mechanical Thrombectomy With Aspiration QEX
    Catheter, Percutaneous, Neurovasculature QJP
    Catheter, Percutaneous DQY
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    Endoscope, Neurological GWG
    Introducer, Catheter DYB

    Proprietary Names

    Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology ASPIRATION PUMP Indigo® Aspiration System Penumbra System (RED 68 Reperfusion Catheter) Penumbra System® (Reperfusion Catheter RED™ 43) Indigo System INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Indigo® Aspiration System – Lightning® Flash Penumbra Separator 054 Penumbra Reperfusion Catheter 054 Benchmark Intracranial Access System Benchmark System Penumbra LP Coil System Penumbra Coil System PC 400 Ruby Coil System Penumbra Engine Pump Access25™ Delivery Microcatheter Benchmark BMX96 System BMX 81 Delivery Catheter Penumbra System (Reperfusion Catheter RED 72) Penumbra Separator Penumbra Reperfusion Catheter Penumbra Aspiration Tubing Penumbra System (Thunderbolt Aspiration Tubing) Penumbra Indigo System JET™7Reperfusion Catheter with MAX Delivery Device (JET™7MAX) Artemis Neuro Evacuation Device Lantern Microcatheter Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Penumbra System ACE 68 Reperfusion Catheter INDIGO® Aspiration System - INDIGO Link POD System Indigo Aspiration System – Lightning Aspiration Tubing Penumbra ACE System Indigo Aspiration System (CAT RX and Separator 4) - Penumbra Engine Pump and Canister Apollo System POD Packing Coil Penumbra System Ruby XL System Indigo® Aspiration System – Lightning Bolt Aspiration Tubing Benchmark BMX96 Access System Penumbra Smart Coil System Element Vascular Access System Penumbra 3D Revascularization Device Penumbra Aspiration System Indigo® Aspiration System – Lightning® Flash Aspiration Tubing Indigo® Aspiration System – Lightning® Bolt Aspiration Tubing MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Neuron Intracranial Access System Indigo Lightning Flash Aspiration System - Select + Catheter Neuron MAX INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra Smart Coil Penumbra High Flow Aspiration Tubing Pump MAX Penumbra DDC Catheters Indigo Aspiration System - Lightning Flash Penumbra System MAX Penumbra Apollo System Reperfusion Catheter RED™ 62 PX 400 MicroCatheter PX SLIM MicroCatheter Velocity MicroCatheter Penumbra POD Embolization Coil Penumbra Ruby Embolization Coil Penumbra PC400 Embolization Coil Penumbra System ACE Indigo Aspiration System - Aspiration Catheter 7, Separator 7, Lighnting 7 Smart Coil Penumbra System Engine Pump Penumbra System JET CAT Rx Neuron Select Catheter Neuron Delivery Catheter

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only