Teleport XT Microcatheter
K-Number: K231608 · 2024-01-07
Decision Date2024-01-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Teleport XT Microcatheter is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-01-07 under approval number K231608. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Teleport XT Microcatheter?
Teleport XT Microcatheter is a medical device that received FDA 510(k) clearance on 2024-01-07. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K231608.
When was Teleport XT Microcatheter approved by the FDA?
Teleport XT Microcatheter received FDA 510(k) clearance on 2024-01-07, under approval number K231608.
What company makes Teleport XT Microcatheter?
Teleport XT Microcatheter is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..
What is the FDA product code for Teleport XT Microcatheter?
The FDA product code for Teleport XT Microcatheter is DQY.
Other Devices by OrbusNeich Medical (Shenzhen) Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.