SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057— 510(k) K091808

Name: FDA 510(k) clearance K091808
Creator: U.S. Food and Drug Administration
Published: 2009-09-10

Unknown

Hansen Medical, Inc.

FDA 510(k) clearance K091808 for SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057, Unknown on 2009-09-10. 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: 2009-06-18
Decision date: 2009-09-10
Decision: Unknown
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K091808

K-number listed on FDA's recall record

Z-0896-2015 — Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.Class II·Terminated·Hansen Medical Inc·20141204

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091808.

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