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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 the device name listed in this FDA 510(k) record. The listed applicant is Hansen Medical, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) 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. The listed applicant is Hansen Medical, Inc.. The 510(k) number is K153304.

When did Hansen Medical Magellan Robotic Catheter eKit receive FDA 510(k) clearance?

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

Who is the listed applicant for Hansen Medical Magellan Robotic Catheter eKit?

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 Magellan Robotic Catheter eKit?

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

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 9Fr

Related Devices (Code: DRA)

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.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICAL

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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