Cleared Traditional

K072156 - OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER

K072156 is an FDA 510(k) clearance for OPTIMUS 0.035 INCH PTA BALLOON DILATATI..., manufactured by Usci Ireland. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K072156 · Usci Ireland · Cardiovascular device
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Nov 2007
Decision
98d
Days
Class 2
Risk

K072156 is an FDA 510(k) clearance for the OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Usci Ireland (North Reading, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 98 days - within the typical 510(k) review window.

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 Usci Ireland devices

FDA 510(k) Submission Details - K072156

510(k) Number K072156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2007
Decision Date November 09, 2007
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 670
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K072156.
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