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Home » Penumbra’s Recalled Clot Retriever Highlights Problems With 510(k) Clearances
Penumbra’s Recalled Clot Retriever Highlights Problems With 510(k) Clearances
The regulatory history of the Penumbra Jet 7 Reperfusion Catheter highlights serious problems with the FDA’s 510(k) clearance pathway, says Kushal Kadakia of Harvard Medical School and co-authors of an article in JAMA Internal Medicine.