Cleared Traditional

K103808 - SAPPHIRE NC

K103808 is an FDA 510(k) clearance for SAPPHIRE NC, manufactured by Orbusneich Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K103808 · Orbusneich Medical, Inc. · Cardiovascular device
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Sep 2011
Decision
246d
Days
Class 2
Risk

K103808 is an FDA 510(k) clearance for the SAPPHIRE NC. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Orbusneich Medical, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on September 1, 2011 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Orbusneich Medical, Inc. devices

FDA 510(k) Submission Details - K103808

510(k) Number K103808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date September 01, 2011
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOX Device Classification - Class 2, Special Controls

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 52
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K103808.
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · Abbott Vascular · Jun 2012
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K113220 · Boston Scientific Corporation · Mar 2012
NC TREK OTW CORONARY DILATATION CATHETER
K113464 · Abbott Vascular · Mar 2012
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
K110617 · Abbott Vascular · Jun 2011
THE PILOT SCIMED TORQUE DEVICE
K896108 · Scimed Life Systems, Inc. · Jan 1990
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
K861847 · Advanced Cardiovascular Systems, Inc. · Jun 1986