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FDA 510(k), K212224, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
FDA 510(k), K212224, TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Regular price
$49.00 USD
Regular price
Sale price
$49.00 USD
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per
510(K) Number: K212224
Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: KXA
Date Received: 07/16/2021
Decision Date: 09/20/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Manufacturer: Kristin Ellis
Device Classification Name: Catheter, Percutaneous, Neurovasculature
Regulation Number: QJP
Classification Product Code: KXA
Date Received: 07/16/2021
Decision Date: 09/20/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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