Cleared Traditional

K102482 - FLASH PTA BALLOON DILATATION CATHETER 5...

Also marketed or referenced as:
FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM

K102482 is an FDA 510(k) clearance for FLASH PTA BALLOON DILATATION CATHETER 5..., 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 179-day FDA review.

K102482 · Ostial Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
179d
Days
Class 2
Risk

K102482 is an FDA 510(k) clearance for the FLASH PTA BALLOON 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 February 25, 2011 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Ostial Corporation devices

FDA 510(k) Submission Details - K102482

510(k) Number K102482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date February 25, 2011
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
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 K102482.
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K103464 · Medtronic, Inc. · Dec 2010
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K103322 · Ev3, Inc. · Dec 2010
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K093965 · C.R. Bard, Inc. · Mar 2010