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
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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.

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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 46
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K130904.
Pulse* Spray Infusion System, Uni*Fuse Infusion System
K163356 · AngioDynamics, Inc. · May 2017
SpeedLyser Infusion Catheter Kit
K170258 · AngioDynamics, Inc. · Feb 2017
Squirt Fluid Delivery System
K162777 · Merit Medical Systems, Inc. · Oct 2016
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · Ekos Corp. · Jun 2008
EndoWave Infusion System
K080392 · Ekos Corp. · Apr 2008
ENDOWAVE INFUSION SYSTEM
K072507 · Ekos Corp. · Oct 2007