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FDA 510(k)

GUIDANT AXIUS CORONARY SHUNT

K-Number: K010117 · 2001-04-04

ApplicantCardiothoracic Systems, Inc.
Decision Date2001-04-04
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDANT AXIUS CORONARY SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 2001-04-04 under 510(k) number K010117. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUIDANT AXIUS CORONARY SHUNT?

GUIDANT AXIUS CORONARY SHUNT is a medical device that received FDA 510(k) clearance on 2001-04-04. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K010117.

When did GUIDANT AXIUS CORONARY SHUNT receive FDA 510(k) clearance?

GUIDANT AXIUS CORONARY SHUNT received FDA 510(k) clearance on 2001-04-04, under 510(k) number K010117.

Who is the listed applicant for GUIDANT AXIUS CORONARY SHUNT?

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

What is the FDA product code for GUIDANT AXIUS CORONARY SHUNT?

The FDA product code for GUIDANT AXIUS CORONARY SHUNT is DXC.

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Other records listing Cardiothoracic Systems, Inc. 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.

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Related Devices (Code: DXC)

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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