Cleared Traditional

K120381 - Q50 PLUS STENT GRAFT BALLOON CATHETER

K120381 is the FDA 510(k) clearance for Q50 PLUS STENT GRAFT BALLOON CATHETER by Qxmedical, LLC. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K120381 · Qxmedical, LLC · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2012
Decision
17d
Days
Class 2
Risk

K120381 is an FDA 510(k) clearance for the Q50 PLUS STENT GRAFT BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Qxmedical, LLC (St. Paul, US). The FDA issued a Cleared decision on February 24, 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. 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 Qxmedical, LLC devices

Submission Details

510(k) Number K120381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2012
Decision Date February 24, 2012
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 574
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