Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hansen Medical Magellan Robotic Catheter 9Fr

K-Number: K160919 · 2016-09-20

ApplicantHansen Medical, Inc.
Decision Date2016-09-20
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hansen Medical Magellan Robotic Catheter 9Fr is a medical device manufactured by Hansen Medical, Inc.. It received FDA 510(k) clearance on 2016-09-20 under approval number K160919. 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 9Fr?

Hansen Medical Magellan Robotic Catheter 9Fr is a medical device that received FDA 510(k) clearance on 2016-09-20. It is manufactured by Hansen Medical, Inc.. The 510(k) number is K160919.

When was Hansen Medical Magellan Robotic Catheter 9Fr approved by the FDA?

Hansen Medical Magellan Robotic Catheter 9Fr received FDA 510(k) clearance on 2016-09-20, under approval number K160919.

What company makes Hansen Medical Magellan Robotic Catheter 9Fr?

Hansen Medical Magellan Robotic Catheter 9Fr is manufactured by Hansen Medical, Inc..

What is the FDA product code for Hansen Medical Magellan Robotic Catheter 9Fr?

The FDA product code for Hansen Medical Magellan Robotic Catheter 9Fr is DRA.

Related Clinical Trials

NCT07612683 Pulmonary Artery Catheters in Cardiac Surgery NOT_YET_RECRUITING NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07537153 Genicular Artery Embolization for Knee Osteoarthritis RECRUITING NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING

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.

K153304Hansen Medical Magellan Robotic Catheter eKit

Related Devices (Code: DRA)

K161985Steerable Guide CatheterAbbott Vascular K152310HeartLight Deflectable SheathCardiofocus, Inc. K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, 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.

↑