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FDA 510(k)

HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER

K-Number: K111004 · 2012-05-29

ApplicantHansen Medical, Inc.
Decision Date2012-05-29
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND 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 2012-05-29 under 510(k) number K111004. The device is classified under product code DXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER?

HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER is a medical device that received FDA 510(k) clearance on 2012-05-29. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K111004.

When did HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER receive FDA 510(k) clearance?

HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER received FDA 510(k) clearance on 2012-05-29, under 510(k) number K111004.

Who is the listed applicant for HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND 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 VASCULAR CATHETER CONTROL SYSTEM AND CATHETER?

The FDA product code for HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER is DXX.

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Other records listing Hansen Medical, Inc. as applicant

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K160919Hansen Medical Magellan Robotic Catheter 9FrK153304Hansen Medical Magellan Robotic Catheter eKitK132369MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FRK102168SENSEI X ROBOTIC CATHETER SYSTEMK091808SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057K090365HANSEN MEDICAL ARTISAN S CONTROL CATHETER

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Related Devices (Code: DXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262744GenesisX RMNStereotaxis, Inc.K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc.K243789LIBERTY Endovascular Robotic System (LIBERTYOS)Microbot Medical , Ltd.K221464CorPath GRX SystemCorindus, Inc.K202275CorPath GRX SystemCorindus, Inc.K180517CorPath GRX SystemCorindus, Inc.

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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