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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 the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical Components, LLC. It received FDA 510(k) clearance on 2017-11-09 under 510(k) 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. The listed applicant is Heraeus Medical Components, LLC. The 510(k) number is K170664.

When did Odyssey Micro Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Odyssey Micro Catheter?

The FDA 510(k) record lists Heraeus Medical Components, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Odyssey Micro Catheter?

The FDA product code for Odyssey Micro Catheter is DQY.

Other records listing Heraeus Medical Components, LLC 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.

K191305Hereaeus Poseidon MicrocatheterK191502Heraeus Peripheral GuidewireK173052Heraeus TMW Guidewire

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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