Cleared Special

K131450 - FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0

K131450 is an FDA 510(k) clearance for FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, 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 78-day FDA review.

K131450 · Ostial Corporation · Cardiovascular device
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Aug 2013
Decision
78d
Days
Class 2
Risk

K131450 is an FDA 510(k) clearance for the FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X .... 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 August 6, 2013 after a review of 78 days - a notably fast clearance 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. 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 Ostial Corporation devices

FDA 510(k) Submission Details - K131450

510(k) Number K131450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date August 06, 2013
Days to Decision 78 days
Submission Type Special
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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 86
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K131450.
CHOCOLATE PTCA BOLLOON CATHETER
K133633 · Trireme Medical, Inc. · Jun 2014
MOZEC - RX PTCA BALLOON DILATATION CATHETER
K131169 · Meril Life Sciences Private Limited · Dec 2013
HOPER PTCA BALLOON CATHETER
K123473 · Lepu Medical Technology (Beijing) Co., Ltd. · Aug 2013
EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT
K130391 · Boston Scientific Corp · Jul 2013
MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN
K123279 · Abbott Vascular · Jan 2013
DK-PTCA BALLOON CATHETER
K123264 · Intuit Medical, LLC · Jan 2013