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FDA 510(k)

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR

K-Number: K132369 · 2013-09-27

ApplicantHansen Medical, Inc.
Decision Date2013-09-27
Product CodeDXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR 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 2013-09-27 under 510(k) number K132369. 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 MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR?

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR is a medical device that received FDA 510(k) clearance on 2013-09-27. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K132369.

When did MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR receive FDA 510(k) clearance?

MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR received FDA 510(k) clearance on 2013-09-27, under 510(k) number K132369.

Who is the listed applicant for MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR?

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 MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR?

The FDA product code for MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR is DXX.

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Other records listing Hansen Medical, Inc. as applicant

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.

K160919Hansen Medical Magellan Robotic Catheter 9FrK153304Hansen Medical Magellan Robotic Catheter eKitK111004HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETERK102168SENSEI 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.

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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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