Pulmonary Embolism Intervention

71 devices 40 with evidence

Clinical Overview

Devices for acute PE treatment including thrombectomy and thrombolysis catheters.

Procedures that use pe devices

Pulmonary Embolism Thrombectomy

Pulmonary Embolism Devices by manufacturer

18 product lines from 5 manufacturers registered with the FDA. Sizes are as listed in the FDA device identification database; confirm with the manufacturer's instructions for use.

Manufacturer	Product	Sizes (FDA GUDID)	Models	MRI
Penumbra, Inc.	Indigo System CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing FDA record Suggest edits	Length: 50–190 cm	75	Not stated
Boston Scientific Corporation	Ekos Suggest edits	—	5	Not stated
Penumbra, Inc.	Indigo System Lightning Bolt 16 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip FDA record Suggest edits	Length: 80–135 cm	4	Not stated
Penumbra, Inc.	Indigo System Lightning Flash Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip FDA record Suggest edits	Length: 80–135 cm	4	Not stated
Thrombolex, Inc.	Bashir Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion Suggest edits	Length: 10–40 cm; Catheter Gauge: 7 Fr	4	Not stated
Penumbra, Inc.	Indigo Aspiration Catheter D Kit FDA record Suggest edits	—	3	Not stated
Inquis Medical, Inc.	Aventus Thrombectomy System The Aventus Thrombectomy System is a catheter-based manual aspiration system designed for minimally invasive removal of emboli and thrombi from pulmonary arteries,… Suggest edits	—	1	Not stated
Inquis Medical, Inc.	Aventus Thrombectomy System - Aspiration Catheter The Aventus Aspiration Catheter is a multi-lumen catheter with a flexible shaft and a tapered radiopaque tip designed to remove thrombus and… Suggest edits	—	1	Not stated
Inari Medical, Inc.	FlowTriever Catheter, Large FlowTriever Catheter, 18 mm Suggest edits	Outer Diameter: 18 mm	1	Not stated
Inari Medical, Inc.	FlowTriever Catheter, M FlowTriever Catheter, 14 mm Suggest edits	Outer Diameter: 14 mm	1	Not stated
Inari Medical, Inc.	FlowTriever Catheter, S Suggest edits	Outer Diameter: 10 mm	1	Not stated
Inari Medical, Inc.	FlowTriever 2 Catheter, M FlorTriever 2 Catheter, Medium, 12Fr, 120 cm Suggest edits	Outer Diameter: 4 mm; Length: 120 cm	1	Not stated
Inari Medical, Inc.	FlowTriever Catheter, XL FlowTriever Catheter, 25 mm Suggest edits	Outer Diameter: 14–25 mm	1	Not stated
Inari Medical, Inc.	Triever16 Curve Triever16 Curve (FlowTriever Retrieval/Aspiration System) Suggest edits	—	1	Not stated
Thrombolex, Inc.	BASHIR .035 Endovascular Catheter Bashir™ .035 Endovascular Catheter 8Fr, 12.5cm basket Suggest edits	Catheter Gauge: 8 Fr; Length: 12.5 cm	1	Not stated
Thrombolex, Inc.	Bashir Endovascular Catheter Suggest edits	—	1	Not stated
Thrombolex, Inc.	BASHIR S-B .035 Endovascular Catheter Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm basket Suggest edits	Catheter Gauge: 8 Fr; Length: 10 cm	1	Not stated
Thrombolex, Inc.	Bashir S-B Endovascular Catheter 7Fr, 10.0cm basket Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket Suggest edits	Catheter Gauge: 7 Fr; Length: 10 cm	1	Not stated

All Manufacturers Boston Scientific Btg International Ekos Inari Medical Irani Medical Parace Penumbra Smithkline Diagnostics All Pathways 510K Any Evidence Level 1+ Studies 2+ Studies 5+ Studies 10+ Studies Filter Clear Filters

Device	Manufacturer	Pathway	Cleared	Evidence
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Evidence	Penumbra	510(k)	2020	40
Indigo Aspiration System Evidence Other clearances: 2017, 2016	Penumbra	510(k)	2019	40
Indigo System Aspiration Catheter 12 Indigo Aspiration System Separator 12 Evidence	Penumbra	510(k)	2020	40
Indigo Aspiration System - Lightning Flash Evidence	Penumbra	510(k)	2022	40
Indigo Aspiration System - Lightning Aspiration Tubing Evidence Other clearances: 2020, 2020	Penumbra	510(k)	2021	40
Indigo Aspiration System Cat RX Aspiration Catheter and Separator 4 Evidence	Penumbra	510(k)	2022	40
Penumbra Embolectomy Aspiration System Indigotm Aspiration System Evidence	Penumbra	510(k)	2016	40
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 Evidence	Penumbra	510(k)	2020	40
Indigo Aspiration System - Penumbra Engine Pump Indigo Aspiration System - Penumbra Engine Pump Canister Evidence	Penumbra	510(k)	2018	40
Penumbra Embolectomy Aspiration System Indigo Aspiration System Evidence	Penumbra	510(k)	2015	40
Indigo System Aspiration Catheter 7 Indigo Aspiration System Separator 7 Lightning 7 Evidence	Penumbra	510(k)	2021	40
Indigo Aspiration System - Modified 110 Aspiration Tubing Evidence	Penumbra	510(k)	2018	40
Indigo Aspiration System Cat RX and Separator 4 - Penumbra Engine Pump and Canister Evidence	Penumbra	510(k)	2018	40
Ekos Ultrasound Infusion System Evidence	Ekos	510(k)	2005	35
Ekos Endovascular Device Evidence	Boston Scientific	510(k)	2022	35
Ekos Peripheral Infusion System Evidence Other clearances: 2003, 2003	Ekos	510(k)	2005	35
Ekosonic Endovascular System with Control Unit 4 0 Evidence	Btg International	510(k)	2017	35
Ekosector I	Smithkline Diagnostics	510(k)	1976	35
Ekos Micro-Infusion System Other clearances: 2006, 2005, 2005	Ekos	510(k)	2007	35
Ekos Ultrasound Evd Device Evd Control Unit	Btg International	510(k)	2018	35
Ekosonic Endovascular Device with Control Unit 4 0 Evidence	Btg International	510(k)	2019	35
Ekosonic Endovascular System Evidence	Btg International	510(k)	2018	35
Parace Md Ekoscope IS100	Parace	510(k)	2013	35
Ekos PE Endovascular Device with Control System 4 0 CS4 0 Evidence	Ekos	510(k)	2020	35
Ekosonic Endovascular Device Ekos Endovascular Device Evidence	Boston Scientific	510(k)	2021	35
Ekosonic Endovascular System with Rapid Pulse Modulation Evidence	Ekos	510(k)	2008	35
Ekosonic Endovascular Device Evidence	Btg International	510(k)	2019	35
Ekosonic Endovascular System Evidence	Ekos	510(k)	2011	35
Ekosonic Endovascular Device Evidence	Boston Scientific	510(k)	2021	35
Ekosonic Mach 4 Endovascular Device Ekosonic Control Unit	Btg International	510(k)	2014	35
ClotTriever Thrombectomy System Evidence Other clearances: 2021, 2019, 2018, 2018, 2017	Inari Medical	510(k)	2023	23
ClotTriever Thrombectormy System ClotTriever Catheter ClotTriever Sheath Evidence	Inari Medical	510(k)	2019	23
ClotTriever Thrombectomy System ClotTriever Catheter ClotTriever Sheath Evidence	Inari Medical	510(k)	2017	23
ClotTriever XL Catheter	Inari Medical	510(k)	2023	23
Mini-Clottriever Thrombectomy System Evidence	Inari Medical	510(k)	2022	23
ClotTriever Bold Catheter	Inari Medical	510(k)	2023	23