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FDA 510(k)

MODIFIED HD GUIDE CATHETER

K-Number: K080583 · 2008-07-18

ApplicantConcentric Medical, Inc.
Decision Date2008-07-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED HD GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical, Inc.. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K080583. 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 MODIFIED HD GUIDE CATHETER?

MODIFIED HD GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K080583.

When did MODIFIED HD GUIDE CATHETER receive FDA 510(k) clearance?

MODIFIED HD GUIDE CATHETER received FDA 510(k) clearance on 2008-07-18, under 510(k) number K080583.

Who is the listed applicant for MODIFIED HD GUIDE CATHETER?

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

What is the FDA product code for MODIFIED HD GUIDE CATHETER?

The FDA product code for MODIFIED HD GUIDE CATHETER is DQY.

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Other records listing Concentric Medical, 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: 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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