📋 FDA Reference
Penumbra System 110 Aspiration Tubing
Product: Penumbra System — all models and sizes · Where to buy
Summary: The Penumbra System 110 Aspiration Tubing is a medical device used in mechanical thrombectomy procedures, primarily for venous applications. It is utilized by interventional radiologists and neurologists to remove blood clots.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151623 ↗
Decision Date ?
August 6, 2015
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System 110 Aspiration Tubing was cleared via the FDA 510(k) pathway on August 6, 2015. Manufactured by Penumbra, it is classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System 110 Aspiration Tubing is part of a mechanical thrombectomy system designed to remove thrombi or blood clots from the vascular system. It works by providing a conduit for aspiration, allowing for the removal of clots through suction. This device is essential in procedures aiming to restore blood flow in cases of acute ischemic stroke or other thrombotic events.
FDA-Cleared Indications
- Use as part of a compatible Penumbra System for the removal of thrombus from the vascular system.
- The specific indication depends on the complete cleared system, compatible catheters, and procedure instructions for use.
- The product code identifies this device category as a catheter or tubing component used with thrombus-retrieval systems.
Clinical Applications
- Aspiration-assisted mechanical thrombectomy for selected venous thromboembolic disease.
- Clot removal during lower-extremity deep vein thrombosis thrombectomy when used with a cleared compatible system.
- Thrombectomy of selected pulmonary emboli when the complete compatible system is cleared for that application.
- Removal of thrombus from dialysis grafts or fistulas when used with an appropriately cleared thrombectomy system.
Reported off-label uses
- Use of aspiration tubing or similar large-bore aspiration systems in vascular territories or clinical situations not specifically included in the applicable device labeling may occur in practice, but such use is off-label and should be evaluated by the treating physician.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- Use only with compatible Penumbra System components and according to the current instructions for use; tubing alone is not a complete thrombectomy device.
- Confirm tubing, catheter, pump, connector, and access-system compatibility before the procedure. Component size and length must match the selected catheter and vascular access plan.
- Maintain a stable catheter position and follow the system instructions for aspiration, flushing, connection, and troubleshooting to reduce air entry, loss of suction, or vessel injury.
- MRI safety depends on the complete assembled system and whether the tubing is present with other components; do not assume MRI compatibility from the tubing name alone. Check the current manufacturer labeling.
- Potential complications are related mainly to the thrombectomy procedure and system use and may include bleeding, vascular injury, embolization, infection, contrast reaction, blood loss, and device malfunction.
Related Literature
The linked study, 'Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3,' likely investigates the efficacy of endovascular therapy in stroke patients, although specific details are unavailable. The study may focus on imaging techniques to evaluate patient suitability for thrombectomy. Limitations include the lack of available abstract and year, which restricts detailed analysis.
Procedures that use this device
Linked Studies (15)
PubMed • 2026
First-Pass Effect With Aspiration Thrombectomy With the Penumbra System in Patients With Acute Ischemic Stroke: A Core Laboratory-Adjudicated Subset Analysis of the COMPLETE Registry.
Stroke (Hoboken, N.J.)
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2023
Aspiration thrombectomy with the Penumbra System for patients with stroke and late onset to treatment: a subset analysis of the COMPLETE registry.
Frontiers in neurology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2022
Endovascular Treatment of Acute Ischemic Stroke With the Penumbra System in Routine Practice: COMPLETE Registry Results.
Stroke
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2019
Efficacy of a coaxial system with a compliant balloon catheter for navigation of the Penumbra reperfusion catheter in tortuous arteries: technique and case experience.
Journal of neurosurgery
View Source →PubMed • 2018
Unilateral Acute Renal Artery Embolism: An Index Case of Successful Mechanical Aspiration Thrombectomy With Use of Penumbra Indigo Aspiration System and a Review of the Literature.
Vascular and endovascular surgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2017
Efficiency of the Penumbra 5MAX ACE Reperfusion Catheter in Acute Ischemic Stroke Patients.
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Mechanical thrombectomy with the penumbra 3D separator and lesional aspiration: technical feasibility and clinical outcome.
Clinical neuroradiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2015
Cerebral Venous Sinus Thrombosis: Successful Treatment of Two Patients Using the Penumbra System and Review of Endovascular Approaches.
The neuroradiology journal
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2012
Rescue forced-suction thrombectomy using the reperfusion catheter of the Penumbra System for thromboembolism during coil embolization of ruptured cerebral aneurysms.
Neurosurgery
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2012
The Penumbra system for mechanical thrombectomy in endovascular acute ischemic stroke therapy.
Neurology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Direct thrombus retrieval using the reperfusion catheter of the penumbra system: forced-suction thrombectomy in acute ischemic stroke.
AJNR. American journal of neuroradiology
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
View Source →ClinicalTrials.gov
A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
View Source →ClinicalTrials.gov
European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke
View Source →Frequently Asked Questions
What is Penumbra System 110 Aspiration Tubing used for?
It is used for mechanical thrombectomy to remove blood clots in patients with venous thrombotic conditions, such as acute ischemic stroke.
What specialties typically use this device?
Interventional radiologists and neurologists commonly use this device in stroke centers and hospitals.
What are the FDA-cleared indications?
It is indicated for mechanical thrombectomy procedures to treat venous thrombotic conditions, particularly in acute ischemic stroke patients.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.