HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH— 510(k) K052480

Clearance details

Applicant

Hansen Medical, Inc.

Product code

Code DXX

Device class

Class 2

Regulation

21 CFR 870.1290

Advisory panel

Cardiovascular

Date received

2005-09-09

Decision date

2007-05-02

Decision

Unknown

Clearance type

Traditional

Location

Mountain View, CA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052480.