Cleared Special

K120738 - FLASH PTA BALLOON DILATATION CATHETER-4...

K120738 is an FDA 510(k) clearance for FLASH PTA BALLOON DILATATION CATHETER-4..., 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 17-day FDA review.

K120738 · Ostial Corporation · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 2012
Decision
17d
Days
Class 2
Risk

K120738 is an FDA 510(k) clearance for the FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Ostial Corporation (Mountain View, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 17 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 - K120738

510(k) Number K120738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2012
Decision Date March 29, 2012
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K120738.
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012
RIVAL PTA DILATATION CATHETER
K120722 · Bard Peripheral Vascular, Inc. · Apr 2012
ATLAS PTA BALLOON DILATATION CATHETER
K120971 · Bard Peripheral Vascular, Inc. · Apr 2012
CONQUEST 40 PTA DILATATION CATHETER
K120660 · Bard Peripheral Vascular, Inc. · Mar 2012
GLADIATOR PTA BALLOON DILATION CATHETER
K113681 · Boston Scientific · Jan 2012
ATB ADVANCE PTA DILATATION CATHETER
K113300 · Cook, Inc. · Dec 2011