Cleared Special

K041649 - SAPPHIRE NXT DETACHABLE COIL SYSTEM

K041649 is the FDA 510(k) clearance for SAPPHIRE NXT DETACHABLE COIL SYSTEM by Micro Therapeutics, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 29-day FDA review.

K041649 · Micro Therapeutics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
29d
Days
Class 2
Risk

K041649 is an FDA 510(k) clearance for the SAPPHIRE NXT DETACHABLE COIL SYSTEM. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on July 16, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device 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.

View all Micro Therapeutics, Inc. devices

Submission Details

510(k) Number K041649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2004
Decision Date July 16, 2004
Days to Decision 29 days
Submission Type Special
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
119d faster than avg
Panel avg: 148d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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 - HCG Device, Neurovascular Embolization

All 100
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K041649.
NEXUS DETACHABLE COIL SYSTEM
K050543 · Micro Therapeutics, Inc. · Apr 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · Boston Scientific Corp · Apr 2005
GDC-10 360 DEGREE COIL SR
K042539 · Boston Scientific Corp · Oct 2004
MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES)
K041551 · MicroVention, Inc. · Jul 2004
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
K040694 · Micro Therapeutics, Inc. · Mar 2004
HYDROCOIL EMBOLIC SYSTEM (HES)
K033836 · MicroVention, Inc. · Dec 2003