FDA 510(k), K190338, 046 Zenith Flex
FDA 510(k), K190338, 046 Zenith Flex
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$149.00 USD
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510(K) Number: K190338
Device Name: 046 Zenith Flex
Manufacturer: Marc Litzenberg
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 02/14/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: 046 Zenith Flex
Manufacturer: Marc Litzenberg
Device Classification Name: Catheter, Thrombus Retriever
Regulation Number: NRY
Classification Product Code: 02/14/2019
Date Received: 08/02/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology