Cleared Traditional

K153304 - Hansen Medical Magellan Robotic Catheter eKit

K153304 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 77-day FDA review.

K153304 · Hansen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
77d
Days
Class 2
Risk

K153304 is an FDA 510(k) clearance for the Hansen Medical Magellan Robotic Catheter eKit. 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 February 1, 2016 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K153304

510(k) Number K153304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2015
Decision Date February 01, 2016
Days to Decision 77 days
Submission Type Traditional
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
48d faster than avg
Panel avg: 125d · This submission: 77d
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 38
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K153304.
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K133552 · Hansen Medical · Feb 2014
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