Cleared Traditional

K013635 - TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH)

Also marketed or referenced as:
TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)

K013635 is an FDA 510(k) clearance for TRELLIS INFUSION SYSTEM (10CM INFUSION ..., manufactured by Bacchus Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code QEY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K013635 · Bacchus Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
98d
Days
Class 2
Risk

K013635 is an FDA 510(k) clearance for the TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH). 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 February 11, 2002 after a review of 98 days - within the typical 510(k) review window.

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 Bacchus Vascular, Inc. devices

FDA 510(k) Submission Details - K013635

510(k) Number K013635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date February 11, 2002
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 49
Devices cleared under the same product code (QEY) and FDA review panel - the closest regulatory comparables to K013635.
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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
Squirt Fluid Delivery System
K981417 · Merit Medical Systems, Inc. · Jul 1998