Penumbra, Inc

FDA Filings

This page includes the latest FDA filings for Penumbra, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Penumbra, Inc.
Indigo Aspiration System2019-12-20
Penumbra, Inc.
Penumbra LP Coil System2019-11-20
Penumbra, Inc.
Artemis Eye System2019-08-30
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 72019-06-16
Penumbra, Inc.
Penumbra System 3D Revascularization Device2019-04-26
Penumbra, Inc.
REAL Immersive System2019-03-18
Penumbra, Inc.
Penumbra System (Modified 110 Aspiration Tubing)2018-10-12
Penumbra, Inc.
Penumbra System Reperfusion Catheter JET 72018-08-17
Penumbra, Inc.
Penumbra System2018-06-20
Penumbra, Inc.
Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX And Separator 4)- Penumbra Engine Pump Canister2018-05-15
Penumbra, Inc.
Indigo Aspiration System - Modified 110 Aspiration Tubing2018-05-03
Penumbra, Inc.
Penumbra Coil 400, Ruby Coil System, POD System2018-04-17
Penumbra, Inc.
Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister2018-03-08
Penumbra, Inc.
Artemis Neuro Evacuation Device2017-08-14
Penumbra, Inc.
POD Packing Coil2017-07-19
PENUMBRA, INC.
INDIGO Aspiration System2017-05-24
Penumbra, Inc.
Penumbra 3D Revascularization Device2017-04-20
Penumbra, Inc.
Penumbra Aspiration System2016-09-26
Penumbra, Inc.
Penumbra System ACE 68 Reperfusion Catheter2016-07-12
Penumbra, Inc.
INDIGO Aspiration System2016-07-01
Penumbra, Inc.
Penumbra System ACE 68 Reperfusion Catheter2016-06-12
PENUMBRA, INC.
Penumbra System, Penumbra Pump MAX2016-05-25
PENUMBRA, INC.
Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)2016-05-24
PENUMBRA, INC.
Penumbra Smart Coil2016-04-20
PENUMBRA, INC.
Apollo System2016-03-17
PENUMBRA, INC.
Penumbra System ACE 64 And ACE 68 Reperfusion Catheters2016-01-13
PENUMBRA, INC.
Lantern Delivery Microcatheter2015-12-02
Penumbra, Inc.
Penumbra System 110 Aspiration Tubing2015-08-06
PENUMBRA, INC.
Penumbra Smart Coil2015-07-10
PENUMBRA, INC.
Penumbra Embolectomy Aspiration System [INDIGO System]2015-05-26

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra Coil 400
PENUMBRA, INC.2020-01-17
Penumbra System
PENUMBRA, INC.2020-01-17
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-10-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-07-09
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Penumbra System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04
Apollo System
PENUMBRA, INC.2019-02-04

Related Finance Registrations
Penumbra Inc of DELAWARE0001321732
Penumbra Fund III | LLC of TEXAS0001572859
Legal Entity Identifier 213800XTO3PC2O2JN281 [PENUMBRA]
Legal Entity Identifier 549300RGE06P3ECANU72 [Penumbra, Inc.]

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