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FDA 510(k)

Hansen Medical Magellan Robotic Catheter eKit

K-Number: K153304 · 2016-02-01

ApplicantHansen Medical, Inc.
Decision Date2016-02-01
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hansen Medical Magellan Robotic Catheter eKit is a medical device manufactured by Hansen Medical, Inc.. It received FDA 510(k) clearance on 2016-02-01 under approval number K153304. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hansen Medical Magellan Robotic Catheter eKit?

Hansen Medical Magellan Robotic Catheter eKit is a medical device that received FDA 510(k) clearance on 2016-02-01. It is manufactured by Hansen Medical, Inc.. The 510(k) number is K153304.

When was Hansen Medical Magellan Robotic Catheter eKit approved by the FDA?

Hansen Medical Magellan Robotic Catheter eKit received FDA 510(k) clearance on 2016-02-01, under approval number K153304.

What company makes Hansen Medical Magellan Robotic Catheter eKit?

Hansen Medical Magellan Robotic Catheter eKit is manufactured by Hansen Medical, Inc..

What is the FDA product code for Hansen Medical Magellan Robotic Catheter eKit?

The FDA product code for Hansen Medical Magellan Robotic Catheter eKit is DRA.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026)

Other Devices by Hansen Medical, Inc.

K160919Hansen Medical Magellan Robotic Catheter 9Fr

Related Devices (Code: DRA)

K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. K161985Steerable Guide CatheterAbbott Vascular K152310HeartLight Deflectable SheathCardiofocus, Inc. K172394Steerable Guide CatheterAbbott Vascular K162925AcQGuide Steerable SheathAcutus Medical, Inc. K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP

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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