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FDA 510(k)

ARTISAN EXTEND CONTROL CATHETER

K-Number: K122275 · 2012-08-29

ApplicantHansen Medical
Decision Date2012-08-29
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARTISAN EXTEND CONTROL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical. It received FDA 510(k) clearance on 2012-08-29 under 510(k) number K122275. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTISAN EXTEND CONTROL CATHETER?

ARTISAN EXTEND CONTROL CATHETER is a medical device that received FDA 510(k) clearance on 2012-08-29. The listed applicant is Hansen Medical. The 510(k) number is K122275.

When did ARTISAN EXTEND CONTROL CATHETER receive FDA 510(k) clearance?

ARTISAN EXTEND CONTROL CATHETER received FDA 510(k) clearance on 2012-08-29, under 510(k) number K122275.

Who is the listed applicant for ARTISAN EXTEND CONTROL CATHETER?

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

What is the FDA product code for ARTISAN EXTEND CONTROL CATHETER?

The FDA product code for ARTISAN EXTEND CONTROL CATHETER is DRA.

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Related Devices (Code: DRA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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