2 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 20, 2019
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021