Cleared Traditional

K121175 - FLASH PTA BALLON DILATATION CATHETER-5M...

K121175 is an FDA 510(k) clearance for FLASH PTA BALLON DILATATION CATHETER-5M..., manufactured by Ostial Corporation. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K121175 · Ostial Corporation · Cardiovascular device
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Jun 2012
Decision
72d
Days
Class 2
Risk

K121175 is an FDA 510(k) clearance for the FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM. 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 June 29, 2012 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ostial Corporation devices

FDA 510(k) Submission Details - K121175

510(k) Number K121175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2012
Decision Date June 29, 2012
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 125d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K121175.
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K120722 · Bard Peripheral Vascular, Inc. · Apr 2012