Cleared Traditional

K130904 - TRELLIS-8 PERIPHERAL INFUSION SYSTEM

K130904 is an FDA 510(k) clearance for TRELLIS-8 PERIPHERAL INFUSION SYSTEM, manufactured by Covidien. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K130904 · Covidien · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
207d
Days
Class 2
Risk

K130904 is an FDA 510(k) clearance for the TRELLIS-8 PERIPHERAL INFUSION SYSTEM. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Covidien (Mansfield, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 207 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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.

FDA 510(k) Submission Details - K130904

510(k) Number K130904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2013
Decision Date October 25, 2013
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QEY Device Classification - Class 2, Special Controls

Product Code QEY Mechanical Thrombolysis Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature.
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 - QEY Mechanical Thrombolysis Catheter

All 70
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K130904.
Occlusion Perfusion Catheter
K153488 · Advanced Catheter Therapies, Inc. · Feb 2016
Occlusion Perfusion Catheter
K151554 · Advanced Catheter Therapies, Inc. · Sep 2015
EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
K140151 · Btg International, Inc. · May 2014
EKOSONIC ENDOVASCULAR SYSTEM
K111705 · Ekos Corporation · Aug 2011
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
K083335 · Omnisonics Medical Technologies · Dec 2008
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
K082199 · Bacchus Vascular, Inc. · Oct 2008
K130904 · TRELLIS-8 PERIPHERAL INFUSION SYSTEM
Download PDF FDA Summary Covidien