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FDA 510(k)

Teleport XT Microcatheter

K-Number: K231608 · 2024-01-07

ApplicantOrbusNeich Medical (Shenzhen) Co., Ltd.
Decision Date2024-01-07
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Teleport XT Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2024-01-07 under 510(k) 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. The listed applicant is OrbusNeich Medical (Shenzhen) Co., Ltd.. The 510(k) number is K231608.

When did Teleport XT Microcatheter receive FDA 510(k) clearance?

Teleport XT Microcatheter received FDA 510(k) clearance on 2024-01-07, under 510(k) number K231608.

Who is the listed applicant for Teleport XT Microcatheter?

The FDA 510(k) record lists OrbusNeich Medical (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Teleport XT Microcatheter?

The FDA product code for Teleport XT Microcatheter is DQY.

Other records listing OrbusNeich Medical (Shenzhen) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P200041Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoringK253361Teleport Glide MicrocatheterK242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)K233499Sapphire NC ULTRA Coronary Dilatation CatheterK233505Sapphire ULTRA Coronary Dilatation CatheterK241025JADE PLUS PTA Balloon Dilatation Catheter

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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.

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