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FDA 510(k)

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057

K-Number: K091808 · 2009-09-10

ApplicantHansen Medical, Inc.
Decision Date2009-09-10
Product CodeDXX
Advisory CommitteeCV
DecisionUnknown

Device Summary

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 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 2009-09-10 under 510(k) number K091808. 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 SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057?

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 is a medical device that received FDA 510(k) clearance on 2009-09-10. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K091808.

When did SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 receive FDA 510(k) clearance?

SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 received FDA 510(k) clearance on 2009-09-10, under 510(k) number K091808.

Who is the listed applicant for SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057?

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 SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057?

The FDA product code for SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 is DXX.

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Other records listing Hansen Medical, Inc. as applicant

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Related Devices (Code: 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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