Cleared Traditional

K160919 - Hansen Medical Magellan Robotic Cathete...

K160919 is an FDA 510(k) clearance for Hansen Medical Magellan Robotic Cathete..., manufactured by Hansen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K160919 · Hansen Medical, Inc. · Cardiovascular device
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Sep 2016
Decision
169d
Days
Class 2
Risk

K160919 is an FDA 510(k) clearance for the Hansen Medical Magellan Robotic Catheter 9Fr. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Hansen Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 20, 2016 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hansen Medical, Inc. devices

FDA 510(k) Submission Details - K160919

510(k) Number K160919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2016
Decision Date September 20, 2016
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRA Catheter, Steerable

All 21
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K160919.
FlexCath Advance Steerable Sheath and Dilator
K183174 · Medtronic Cryocath, LP · Nov 2018
Steerable Guide Catheter
K172394 · Abbott Vascular · Sep 2017
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Steerable Guide Catheter
K161985 · Abbott Vascular · Aug 2016
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006