Cleared Special

K122379 - FLASH PTA BALLOON DILATATION CATHETER -...

K122379 is an FDA 510(k) clearance for FLASH PTA BALLOON DILATATION CATHETER -..., 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.

K122379 · Ostial Corporation · Cardiovascular device
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Sep 2012
Decision
30d
Days
Class 2
Risk

K122379 is an FDA 510(k) clearance for the FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON.... 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 September 5, 2012 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 - K122379

510(k) Number K122379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2012
Decision Date September 05, 2012
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 K122379.
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
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K121856 · C.R. Bard, Inc. · Jul 2012
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K121265 · Medtronic, Inc. · May 2012
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K112797 · Cordis Corp. · May 2012