Cleared Traditional

K103657 - SAPPHIRE

K103657 is an FDA 510(k) clearance for SAPPHIRE, 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 237-day FDA review.

K103657 · Orbusneich Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
237d
Days
Class 2
Risk

K103657 is an FDA 510(k) clearance for the SAPPHIRE. 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 August 9, 2011 after a review of 237 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.

FDA 510(k) Submission Details - K103657

510(k) Number K103657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2010
Decision Date August 09, 2011
Days to Decision 237 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
112d slower than avg
Panel avg: 125d · This submission: 237d
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 86
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K103657.
GLIDER PTCA BALLOON CATHETER
K111544 · Trireme Medical, Inc. · Mar 2012
SAPPHIRE NC
K103808 · Orbusneich Medical, Inc. · Sep 2011
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
K111284 · Ostial Corporation · Aug 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · Creganna-Tactx Medical · Jun 2011
MINI TREK RX 1.20 MM CORONARY DILATATION CATHETER, MINI TREK OTW 1.20 MM CORONARY DILATATION CATHETER
K110617 · Abbott Vascular · Jun 2011
NC TREK RX CORONARY DILATATION CATHETER
K110134 · Abbott Vascular-Cardiac Therapies · Feb 2011