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FDA 510(k)

HANSEN MEDICAL ARTISAN S CONTROL CATHETER

K-Number: K090365 · 2009-05-07

ApplicantHansen Medical, Inc.
Decision Date2009-05-07
Product CodeDXX
Advisory CommitteeCV
DecisionUnknown

Device Summary

HANSEN MEDICAL ARTISAN S CONTROL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical, Inc.. It received FDA 510(k) clearance on 2009-05-07 under 510(k) number K090365. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HANSEN MEDICAL ARTISAN S CONTROL CATHETER?

HANSEN MEDICAL ARTISAN S CONTROL CATHETER is a medical device that received FDA 510(k) clearance on 2009-05-07. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K090365.

When did HANSEN MEDICAL ARTISAN S CONTROL CATHETER receive FDA 510(k) clearance?

HANSEN MEDICAL ARTISAN S CONTROL CATHETER received FDA 510(k) clearance on 2009-05-07, under 510(k) number K090365.

Who is the listed applicant for HANSEN MEDICAL ARTISAN S CONTROL CATHETER?

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

What is the FDA product code for HANSEN MEDICAL ARTISAN S CONTROL CATHETER?

The FDA product code for HANSEN MEDICAL ARTISAN S CONTROL CATHETER is DXX.

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Other records listing Hansen Medical, Inc. as applicant

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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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