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FDA 510(k)

Teleport Microcatheter

K-Number: K182360 · 2018-11-09

ApplicantOrbusneich Medical Trading, Inc.
Decision Date2018-11-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Teleport Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182360. 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 Microcatheter?

Teleport Microcatheter is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K182360.

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

Teleport Microcatheter received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182360.

Who is the listed applicant for Teleport Microcatheter?

The FDA 510(k) record lists Orbusneich Medical Trading, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Teleport Microcatheter?

The FDA product code for Teleport Microcatheter is DQY.

Other records listing Orbusneich Medical Trading, Inc. as applicant

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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.

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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.

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