Cleared Traditional

K111004 - HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER

K111004 is an FDA 510(k) clearance for HANSEN MEDICAL VASCULAR CATHETER CONTRO..., manufactured by Hansen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 414-day FDA review.

K111004 · Hansen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
414d
Days
Class 2
Risk

K111004 is an FDA 510(k) clearance for the HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Hansen Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 29, 2012 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K111004

510(k) Number K111004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2011
Decision Date May 29, 2012
Days to Decision 414 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
289d slower than avg
Panel avg: 125d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
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 - DXX System, Catheter Control, Steerable

All 32
Devices cleared under the same product code (DXX) and FDA review panel - the closest regulatory comparables to K111004.
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K102168 · Hansen Medical, Inc. · Oct 2010
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K090365 · Hansen Medical, Inc. · May 2009