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FDA 510(k), K231168, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
FDA 510(k), K231168, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
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510(K) Number: K231168
Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Manufacturer: Shivani Patel
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 04/25/2023
Date Received: 05/22/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
Manufacturer: Shivani Patel
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: 04/25/2023
Date Received: 05/22/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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