BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Penumbra Inc.

    Reg #: 3013758550 · FEI: 3013758550 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    76
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Penumbra Inc.
    Registration Number
    3013758550
    FEI Number
    3013758550
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6262 Patterson Pass Rd., Suite E, Suite F
    City
    Livermore
    State
    CA
    ZIP
    94550
    Country
    US

    Regulatory Submissions

    510(k) Number
    K250690

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

    Proprietary Names

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

    Establishment Types

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