Cleared Traditional

K070161 - QUATTRO CATHETER MODEL IC4593

K070161 is an FDA 510(k) clearance for QUATTRO CATHETER MODEL IC4593, manufactured by Alsius Corp.. The device is a Class 2 Neurology device with product code NCX cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K070161 · Alsius Corp. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
29d
Days
Class 2
Risk

K070161 is an FDA 510(k) clearance for the QUATTRO CATHETER MODEL IC4593. Classified as System, Hypothermia, Intravenous, Cooling (product code NCX), Class II - Special Controls.

Submitted by Alsius Corp. (Irvine, US). The FDA issued a Cleared decision on February 15, 2007 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.5900 - the FDA neurology device 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 - K070161

510(k) Number K070161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2007
Decision Date February 15, 2007
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NCX Device Classification - Class 2, Special Controls

Product Code NCX System, Hypothermia, Intravenous, Cooling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5900
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 Neurology devices follow this clearance model.

Regulatory Peers - NCX System, Hypothermia, Intravenous, Cooling

All 25
Devices cleared under the same product code (NCX) and FDA review panel - the closest regulatory comparables to K070161.
THERMOGARD XP THERMAL REGULATION SYSTEM
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REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
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REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K071008 · Radiant Medical · May 2007
THERMOGARD THERMAL REGULATION SYSTEM
K063829 · Alsius Corp. · Jan 2007
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
K063405 · Radiant Medical · Jan 2007
COOLGARD 3000
K060308 · Alsius Corp. · Apr 2006
K070161 · QUATTRO CATHETER MODEL IC4593
Download PDF FDA Summary Alsius Corp.