Cleared Special

K032261 - Trellis Reserve Infusion System

K032261 is an FDA 510(k) clearance for Trellis Reserve Infusion System, manufactured by Bacchus Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Special 510(k) pathway after a 30-day FDA review.

K032261 · Bacchus Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
30d
Days
Class 2
Risk

K032261 is an FDA 510(k) clearance for the Trellis Reserve Infusion System. Classified as Mechanical Thrombolysis Catheter (product code QEY), Class II - Special Controls.

Submitted by Bacchus Vascular, Inc. (Santa Clara, US). The FDA issued a Cleared decision on August 22, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bacchus Vascular, Inc. devices

FDA 510(k) Submission Details - K032261

510(k) Number K032261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2003
Decision Date August 22, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 49
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K032261.
LYSUS INFUSION SYSTEM
K041629 · Ekos Corp. · Aug 2004
SPEEDLYSER INFUSION CATHETER KIT
K033443 · AngioDynamics, Inc. · Nov 2003
EKOS PERIPHERAL INFUSION SYSTEM
K033214 · Ekos Corp. · Oct 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · Ekos Corp. · Jul 2003
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K992231 · Merit Medical Systems, Inc. · Jul 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · Merit Medical Systems, Inc. · Jun 1999