Cleared Traditional

K112281 - GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112281 · Trireme Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
8d
Days
Class 2
Risk

K112281 is an FDA 510(k) clearance for the GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX,.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Trireme Medical, Inc. (Pleasonton, US). The FDA issued a Cleared decision on August 17, 2011 after a review of 8 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 Trireme Medical, Inc. devices

Submission Details

510(k) Number K112281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date August 17, 2011
Days to Decision 8 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
117d faster than avg
Panel avg: 125d · This submission: 8d
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

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