Magellan Robotic System— 510(k) K151730

Substantially Equivalent

Hansen Medical, Inc.

FDA 510(k) clearance K151730 for Magellan Robotic System, Substantially Equivalent on 2015-07-23. Applicant: Hansen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Hansen Medical, Inc.
Product code: Code DXX
Device class: Class 2
Regulation: 21 CFR 870.1290
Advisory panel: Cardiovascular
Date received: 2015-06-26
Decision date: 2015-07-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hansen Medical, Inc.

Recalls naming K151730

K-number listed on FDA's recall record

Z-1564-2016 — Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.Class II·Terminated·Hansen Medical Inc·20160325

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151730.

Data sourced from openFDA. This site is unofficial and independent of the FDA.