Neuro aspiration catheters
Penumbra System
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Penumbra System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 3MAXC | — | Not stated | Available |
| 3MAXC-A | Length 160 cm | Not stated | Available |
| 3MAXC-B | Length 160 cm | Not stated | Available |
| 3MAXCKIT | — | Not stated | Available |
| 3MAXCKIT-A | — | Not stated | Available |
| 3MAXCKIT-B | — | Not stated | Available |
| 3MAXS | — | Not stated | Available |
| 4MAXC | — | Not stated | Available |
| 4MAXC130 | Length 130 cm | Not stated | Available |
| 4MAXCKIT | — | Not stated | Available |
| 4MAXCMP | — | Not stated | Available |
| 5MAXACE064-A | Length 132 cm | Not stated | Available |
| 5MAXACE064KIT-A | — | Not stated | Available |
| 5MAXACE064L115-A | Length 115 cm | Not stated | Available |
| 5MAXACE064L120-A | Length 120 cm | Not stated | Available |
| 5MAXACE064L125-A | Length 125 cm | Not stated | Available |
| 5MAXACE064L127-A | Length 127 cm | Not stated | Available |
| 5MAXACE068-A | — | Not stated | Available |
| 5MAXACE068-B | — | Not stated | Available |
| 5MAXACE068KIT-A | — | Not stated | Available |
| 5MAXACE068KIT-B | — | Not stated | Available |
| 5MAXACE068L115-A | — | Not stated | Available |
| 5MAXACE068L115-B | — | Not stated | Available |
| 5MAXACE068L120-A | — | Not stated | Available |
| 5MAXACE068L120-B | — | Not stated | Available |
| 5MAXACE068L125-A | — | Not stated | Available |
| 5MAXACE068L125-B | — | Not stated | Available |
| 5MAXACE068L127-A | — | Not stated | Available |
| 5MAXACE068L127-B | — | Not stated | Available |
| 5MAXACE115 | Length 115 cm | Not stated | Available |
| 5MAXACE125 | Length 125 cm | Not stated | Available |
| 5MAXACE125-A | — | Not stated | Available |
| 5MAXACE127 | Length 127 cm | Not stated | Available |
| 5MAXACE127-A | — | Not stated | Available |
| 5MAXACE132 | Length 132 cm | Not stated | Available |
| 5MAXACE132-A | — | Not stated | Available |
| 5MAXACE132KIT-A | — | Not stated | Available |
| 5MAXJET7 | — | Not stated | Available |
| 5MAXJET7-A | — | Not stated | Available |
| 5MAXJET7-B | — | Not stated | Available |
| 5MAXJET7-R | Length 132 cm | Not stated | Available |
| 5MAXJET7-S | Length 132 cm | Not stated | Available |
| 5MAXJET7B-A | Length 132 cm | Not stated | Available |
| 5MAXJET7BKIT-A | — | Not stated | Available |
| 5MAXJET7BL115-A | Length 115 cm | Not stated | Available |
| 5MAXJET7BL120-A | Length 120 cm | Not stated | Available |
| 5MAXJET7BL125-A | Length 125 cm | Not stated | Available |
| 5MAXJET7BL127-A | Length 127 cm | Not stated | Available |
| 5MAXJET7KIT | — | Not stated | Available |
| 5MAXJET7KIT-A | — | Not stated | Available |
| 5MAXJET7KIT-B | — | Not stated | Available |
| 5MAXJET7KIT-R | — | Not stated | Available |
| 5MAXJET7KIT-S | — | Not stated | Available |
| 5MAXJET7L115 | — | Not stated | Available |
| 5MAXJET7L115-A | — | Not stated | Available |
| 5MAXJET7L115-B | — | Not stated | Available |
| 5MAXJET7L120 | — | Not stated | Available |
| 5MAXJET7L120-A | — | Not stated | Available |
| 5MAXJET7L120-B | — | Not stated | Available |
| 5MAXJET7L125 | — | Not stated | Available |
| 5MAXJET7L125-A | — | Not stated | Available |
| 5MAXJET7L125-B | — | Not stated | Available |
| 5MAXJET7L127 | — | Not stated | Available |
| 5MAXJET7L127-A | — | Not stated | Available |
| 5MAXJET7L127-B | — | Not stated | Available |
| 5MAXJET7L138-B | Length 138 cm | Not stated | Available |
| 5MAXJET7L138KIT-B | Length 138 cm | Not stated | Available |
| ACE603D3MXSYS-A | — | Not stated | Available |
| ACE643D3MXSYS-A | — | Not stated | Available |
| ACE643DVELSYS-A | — | Not stated | Available |
| ACE683D3MXSYS-A | — | Not stated | Available |
| ACE683DVELSYS-A | — | Not stated | Available |
| J7XBKIT132-A | — | Not stated | Available |
| J7XBKIT132-B | — | Not stated | Available |
| J7XKIT132 | — | Not stated | Available |
| J7XKIT132-A | — | Not stated | Available |
| JET73DVELSYS-A | — | Not stated | Available |
| PAPS3 | — | Not stated | Available |
| PAPS3-A | — | Not stated | Available |
| PMXENGN | — | MR Unsafe | Available |
| PMXENGN-A | — | MR Unsafe | Available |
| PSC026 | — | Not stated | Available |
| PSC032 | — | Not stated | Available |
| PSC041 | — | Not stated | Available |
| PSC054-B | Length 132 cm | Not stated | Available |
| PSC054KIT | — | Not stated | Available |
| PSC054L125-B | Length 125 cm | Not stated | Available |
| PSC054L127-B | Length 127 cm | Not stated | Available |
| PSF026 | — | Not stated | Available |
| PSF032 | — | Not stated | Available |
| PSF041 | — | Not stated | Available |
| PSF054 | — | Not stated | Available |
| PSR3D | — | Not stated | Available |
| PSR3D-A | — | Not stated | Available |
| PSR3D-C | — | Not stated | Available |
| PSS026 | — | Not stated | Available |
| PSS032 | — | Not stated | Available |
| PSS041 | — | Not stated | Available |
| PSS054 | — | Not stated | Available |
| PST1 | — | Not stated | Available |
| PST2 | — | Not stated | Available |
| PST3 | — | Not stated | Available |
| RH1-A | — | Not stated | Available |
| SCH1 | — | Not stated | Available |
FDA clearances
- 510(k) K191946 February 2020
- 510(k) K173761 August 2018
- 510(k) K180008 June 2018
- 510(k) K162901 April 2017
- 510(k) K161640 July 2016
- 510(k) K160449 May 2016
- 510(k) K152840 December 2015
- 510(k) K151623 August 2015
- 510(k) K142458 May 2015
- 510(k) K113163 November 2011
- 510(k) K100769 May 2010
- 510(k) K090752 September 2009
- 510(k) K072718 December 2007
Procedures that use neuro aspiration catheters
Frequently asked questions
What is Penumbra System used for?
A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.
Who makes Penumbra System?
Penumbra System is made by Penumbra, Inc.. It is listed under neurovascular aspiration catheters, microcatheters, embolization coils, stent retrievers for stroke in our device library.
What sizes does Penumbra System come in?
Sizes listed for Penumbra System: Length: 115–160 cm. Confirm availability with the manufacturer's instructions for use.
Is Penumbra System MRI safe?
The FDA device database entry for Penumbra System does not state its MRI safety status. Check the labeling before MRI.
Is Penumbra System FDA cleared?
Penumbra System is covered by FDA submissions K173761, K072718, K180008, K100769, K113163, K142458.
How do I contact a Penumbra, Inc. sales representative?
Penumbra, Inc. has not listed representatives on LA Vascular yet. Visit the Penumbra, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.