BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Penumbra Inc.

    Reg #: 3015615738 · FEI: 3015615738 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    76
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    Penumbra Inc.
    Registration Number
    3015615738
    FEI Number
    3015615738
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1070 SOUTH 3800 WEST, SUITE 500
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    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
    Coronary Mechanical Thrombectomy With Aspiration QEX
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Introducer, Catheter DYB
    Catheter, Percutaneous DQY
    Catheter, Percutaneous, Neurovasculature QJP
    Endoscope, Neurological GWG
    Device, Neurovascular Embolization HCG
    Device, Vascular, For Promoting Embolization KRD
    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 (CAT RX Aspiration Catheter and Separator 4) Element Vascular Access System Indigo® Aspiration System - Aspiration Catheter 12 and Separator 12 Indigo Lightning Flash Aspiration System - Select + Catheter Penumbra Engine Pump INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK Penumbra Indigo System Benchmark System Indigo® Aspiration System – Lightning® Flash MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) Penumbra System (Reperfusion Catheter RED 72) Penumbra System MAX Penumbra Apollo System Penumbra System ACE 68 Reperfusion Catheter Penumbra LP Coil System Penumbra Coil System PC 400 Ruby Coil System Ruby XL System Neuron Intracranial Access System Penumbra Smart Coil System Penumbra Aspiration System Penumbra System Indigo® Aspiration System – Lightning® Flash Aspiration Tubing Indigo® Aspiration System – Lightning® Bolt Aspiration Tubing Penumbra System Engine Pump Penumbra System ACE Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology Neuron Select Catheter Neuron Delivery Catheter Penumbra 3D Revascularization Device Indigo Aspiration System - Lightning Flash POD System JET™7Reperfusion Catheter with MAX Delivery Device (JET™7MAX) CAT Rx Indigo® Aspiration System – Lightning Bolt Aspiration Tubing POD Packing Coil Benchmark BMX96 Access System Neuron MAX Penumbra DDC Catheters Indigo System Access25™ Delivery Microcatheter Indigo Aspiration System - Aspiration Catheter 7, Separator 7, Lighnting 7 Indigo Aspiration System – Lightning Aspiration Tubing Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra Separator 054 Penumbra Reperfusion Catheter 054 Penumbra System (RED 68 Reperfusion Catheter) Penumbra System (Thunderbolt Aspiration Tubing) Smart Coil BMX 81 Delivery Catheter Artemis Neuro Evacuation Device Penumbra High Flow Aspiration Tubing PX 400 MicroCatheter PX SLIM MicroCatheter Velocity MicroCatheter Penumbra ACE System Benchmark Intracranial Access System INDIGO® Aspiration System - INDIGO Link ASPIRATION PUMP Penumbra POD Embolization Coil Penumbra Ruby Embolization Coil Penumbra PC400 Embolization Coil Reperfusion Catheter RED™ 62 Penumbra System JET Penumbra Separator Penumbra Reperfusion Catheter Penumbra Aspiration Tubing Indigo Aspiration System (CAT RX and Separator 4) - Penumbra Engine Pump and Canister Lantern Microcatheter Pump MAX Indigo® Aspiration System Benchmark BMX96 System Penumbra Smart Coil Apollo System

    Establishment Types

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