Cleared Special

K150946 - FLASH Ostial System OTW-6.0mm x 12mm x 80cm

K150946 is an FDA 510(k) clearance for FLASH Ostial System OTW-6.0mm x 12mm x 80cm, manufactured by Ostial Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Special 510(k) pathway after a 30-day FDA review.

K150946 · Ostial Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
30d
Days
Class 2
Risk

K150946 is an FDA 510(k) clearance for the FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x .... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Ostial Corporation (Sunnyvale, US). The FDA issued a Cleared decision on May 8, 2015 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 - K150946

510(k) Number K150946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2015
Decision Date May 08, 2015
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 262
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K150946.
Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
K143193 · Boston Scientific · Jul 2015
Armada 18 PTA Catheter
K151317 · Abbott Vascular · Jul 2015
XXL Vascular Balloon Dilatation Catheter
K150303 · Boston Scientific Corp · Jun 2015
Passeo-35 PTA Catheter
K142379 · Biotronik, Inc. · Dec 2014
Fortrex 0.035 OTW PTA Balloon Catheter
K142654 · Covidien, LLC · Oct 2014
PTA BALLOON DILATATION CATHETER
K141150 · Boston Scientific Corp · Sep 2014