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FDA 510(k)

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131

K-Number: K091703 · 2009-10-14

ApplicantConcentric Medical, Inc.
Decision Date2009-10-14
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 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 2009-10-14 under 510(k) number K091703. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131?

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 is a medical device that received FDA 510(k) clearance on 2009-10-14. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K091703.

When did HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 receive FDA 510(k) clearance?

HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 received FDA 510(k) clearance on 2009-10-14, under 510(k) number K091703.

Who is the listed applicant for HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131?

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 HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131?

The FDA product code for HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 is QEZ.

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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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