📋 FDA Reference
Penumbra System Reperfusion Catheter Red 62
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Summary: The Penumbra System Reperfusion Catheter RED 62 is a medical device used in mechanical thrombectomy procedures to remove clots from venous systems. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K203440 ↗
Decision Date ?
May 20, 2021
Product Code ?
NRY Catheter, Thrombus Retriever
Device Class ?
Class 2
Evidence ?
15 studies
The Penumbra System Reperfusion Catheter RED 62 was cleared via the FDA 510(k) pathway on May 20, 2021. It is manufactured by Penumbra and classified as a Class 2 device under product code NRY.
What It Is
The Penumbra System Reperfusion Catheter RED 62 is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to reach and remove thrombi, or clots, from veins. The device is part of a broader system that may include aspiration pumps and other accessories to facilitate clot removal. Its design allows for efficient navigation and clot retrieval in complex venous anatomy.
FDA-Cleared Indications
- Removal of thrombus from the venous system.
- Use in mechanical thrombectomy procedures when endovascular clot removal is clinically appropriate.
Clinical Applications
- Image-guided mechanical thrombectomy for venous thromboembolism.
- Removal of clot from the pulmonary arteries in selected pulmonary embolism procedures.
- Removal of clot from the deep veins in selected deep vein thrombosis procedures.
- Use with compatible aspiration equipment and accessories as part of an endovascular thrombectomy system.
Practical Considerations
- The catheter is intended for use by trained clinicians in an interventional suite or catheterization laboratory with fluoroscopic imaging.
- The catheter is used with compatible guidewires, aspiration equipment and other system accessories; clinicians should confirm compatibility in the current instructions for use.
- Selection of catheter size and technique depends on the target vessel, clot burden, venous anatomy and the patient's clinical condition.
- Potential complications of venous thrombectomy include bleeding, vascular injury, embolization, contrast reaction, infection and complications related to anticoagulation or anesthesia.
- MRI safety and conditions depend on the complete device system and the current manufacturer labeling. The device should not be assumed to be MRI safe without checking the instructions for use.
Related Literature
The linked study titled 'Systemic Thrombolysis Versus Catheter Directed Management for Acute Intermediate-high Pulmonary Embolism' explores the efficacy of catheter-directed interventions compared to systemic thrombolysis in treating pulmonary embolism. While specific details and findings are not available, such studies generally aim to determine the safety and effectiveness of localized clot removal techniques. Limitations may include sample size and the lack of long-term outcome data.
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 the Penumbra System Reperfusion Catheter RED 62 used for?
It is used for mechanical thrombectomy to remove clots from the venous system, particularly in cases of pulmonary embolism or deep vein thrombosis.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for the removal of thrombi from the venous system in conditions like pulmonary embolism and deep vein thrombosis.
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.