Cleared Special

K113775 - FLASH-C PTCA BALLOON DILATATION CATHETE...

K113775 is an FDA 510(k) clearance for FLASH-C PTCA BALLOON DILATATION CATHETE..., manufactured by Ostial Corporation. The device is a Class 2 Cardiovascular device with product code LOX cleared through the Special 510(k) pathway after a 190-day FDA review.

K113775 · Ostial Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2012
Decision
190d
Days
Class 2
Risk

K113775 is an FDA 510(k) clearance for the FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM .... Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Ostial Corporation (Mountain View, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 190 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ostial Corporation devices

FDA 510(k) Submission Details - K113775

510(k) Number K113775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2011
Decision Date June 29, 2012
Days to Decision 190 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 125d · This submission: 190d
Pathway characteristics
Modification to existing cleared device.

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 K113775.
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
K123279 · Abbott Vascular · Jan 2013
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)
K121196 · Boston Scientific Corp · Aug 2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
K121667 · Boston Scientific Corp · Aug 2012
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