Cleared Traditional

K130904 - TRELLIS-8 PERIPHERAL INFUSION SYSTEM (FDA 510(k) Clearance)

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

K130904 · Covidien · Cardiovascular device
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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.

View all Covidien devices

Submission Details

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
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.

Device Classification

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.
Versus™ Catheter (VS110-9NB)
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VariFuse Adjustable Infusion Catheter
K251318 · Argon Medical Devices, Inc. · Jan 2026
Versus™ Catheter (VS110-8B)
K241851 · Liquet Medical, Inc. · Nov 2024
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter
K231653 · Thrombolex, Inc. · Jul 2023
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
K222095 · Thrombolex, Inc. · Apr 2023
EKOS+ Endovascular Device
K220866 · Boston Scientific · Apr 2022