Cleared Special

K133552 - MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT

K133552 is an FDA 510(k) clearance for MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AN..., manufactured by Hansen Medical. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 80-day FDA review.

K133552 · Hansen Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
80d
Days
Class 2
Risk

K133552 is an FDA 510(k) clearance for the MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6.... Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Hansen Medical (Mountain View, US). The FDA issued a Cleared decision on February 7, 2014 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133552

510(k) Number K133552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2013
Decision Date February 07, 2014
Days to Decision 80 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 38
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K133552.
HeartLight Deflectable Sheath
K152310 · Cardiofocus, Inc. · Feb 2016
Hansen Medical Magellan Robotic Catheter eKit
K153304 · Hansen Medical, Inc. · Feb 2016
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
K151463 · Hansen Medical, Inc. · Aug 2015
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · Medtronic Cryocath, LP · Dec 2012
ARTISAN EXTEND CONTROL CATHETER
K122275 · Hansen Medical · Aug 2012
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
K120086 · Cardiosolutions · Apr 2012