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FDA 510(k)

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH

K-Number: K052480 · 2007-05-02

ApplicantHansen Medical, Inc.
Decision Date2007-05-02
Product CodeDXX
Advisory CommitteeCV
DecisionUnknown

Device Summary

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH 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 2007-05-02 under 510(k) number K052480. 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 CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH?

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH is a medical device that received FDA 510(k) clearance on 2007-05-02. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K052480.

When did HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH receive FDA 510(k) clearance?

HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH received FDA 510(k) clearance on 2007-05-02, under 510(k) number K052480.

Who is the listed applicant for HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH?

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 CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH?

The FDA product code for HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH is DXX.

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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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