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Lake Region Medical

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories1
Latest FDA decision2026-03-19
TypeNumberDevice NameCodeDateActions
510(k) K253746 Enroute 0.014'' Transcarotid GuidewireDQX2026-03-19 View
510(k) K242824 PTFE GuidewireDQX2024-12-06 View
510(k) K221575 Pre-Formed BlueDQX2022-10-07 View
510(k) K211741 Pre-Formed Extra Support GuidewireDQX2021-11-22 View
510(k) K160643 ENROUTE 0.014 GuidewireDQX2016-10-18 View
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