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FDA 510(k)

CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072

K-Number: K021899 · 2002-07-10

ApplicantConcentric Medical, Inc.
Decision Date2002-07-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 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 2002-07-10 under 510(k) number K021899. 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 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072?

CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 is a medical device that received FDA 510(k) clearance on 2002-07-10. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K021899.

When did CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 receive FDA 510(k) clearance?

CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 received FDA 510(k) clearance on 2002-07-10, under 510(k) number K021899.

Who is the listed applicant for CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072?

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 CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072?

The FDA product code for CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072 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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