Class I Recall of Stroke Catheter (Penumbra System Reperfusion Catheter 032)
Abstract:The Penumbra System Reperfusion Catheter 032 was marketed as a device used to re-establish blood supply to the brain, in patients experiencing stroke. However, the device maker Penumbra, after consultation with the FDA, issued a class I recall on their Reperfusion Catheters 032, belonging to lot F15020.
Compliance Trainings
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
By - Jose Mora
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By - Jose Mora
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QA Agreements for ISO 13485:2019 and other Regulatory Compliance
By - Betty Lane
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By - Betty Lane
On Demand Access Anytime
Compliance Standards
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