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FDA 510(k)

Odyssey Micro Catheter

K-Number: K170664 · 2017-11-09

ApplicantHeraeus Medical Components, LLC
Decision Date2017-11-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Odyssey Micro Catheter is a medical device manufactured by Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2017-11-09 under approval number K170664. 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 Odyssey Micro Catheter?

Odyssey Micro Catheter is a medical device that received FDA 510(k) clearance on 2017-11-09. It is manufactured by Heraeus Medical Components, LLC. The 510(k) number is K170664.

When was Odyssey Micro Catheter approved by the FDA?

Odyssey Micro Catheter received FDA 510(k) clearance on 2017-11-09, under approval number K170664.

What company makes Odyssey Micro Catheter?

Odyssey Micro Catheter is manufactured by Heraeus Medical Components, LLC.

What is the FDA product code for Odyssey Micro Catheter?

The FDA product code for Odyssey Micro Catheter is DQY.

Related Clinical Trials

NCT05996159 Pulmonary Vein Isolation Strategy of Very High Power Short Duration in Patients With Paroxysmal Atrial Fibrillation RECRUITING

Other Devices by Heraeus Medical Components, LLC

K173052Heraeus TMW Guidewire K191305Hereaeus Poseidon Microcatheter K191502Heraeus Peripheral Guidewire

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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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