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FDA 510(k)

Teleport Glide Microcatheter

K-Number: K253361 · 2026-04-10

Decision Date2026-04-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Teleport Glide Microcatheter is a medical device manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-10 under approval number K253361. 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 Glide Microcatheter?

Teleport Glide Microcatheter is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K253361.

When was Teleport Glide Microcatheter approved by the FDA?

Teleport Glide Microcatheter received FDA 510(k) clearance on 2026-04-10, under approval number K253361.

What company makes Teleport Glide Microcatheter?

Teleport Glide Microcatheter is manufactured by OrbusNeich Medical (Shenzhen) Co., Ltd..

What is the FDA product code for Teleport Glide Microcatheter?

The FDA product code for Teleport Glide Microcatheter is DQY.

Other Devices by OrbusNeich Medical (Shenzhen) Co., Ltd.

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Related Devices (Code: DQY)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.