BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Penumbra Inc.

    Reg #: 3016591327 · FEI: 3016591327 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    77
    Establishment Types
    2
    Classifications
    12

    Registration Details

    Registration Name
    Penumbra Inc.
    Registration Number
    3016591327
    FEI Number
    3016591327
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    630 Roseville Parkway
    City
    Roseville
    State
    CA
    ZIP
    95747
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222808

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

    Proprietary Names

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

    Establishment Types

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