Cleared Traditional

ANCURE LLIAC BALLOON CATHETER (K003495) - FDA 510(k) Clearance

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

K003495 · Guidant Cardiac and Vascular Surgery · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
86d
Days
Class 2
Risk

K003495 is an FDA 510(k) clearance for the ANCURE LLIAC BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Cardiac and Vascular Surgery (Menlo Park, US). The FDA issued a Cleared decision on February 7, 2001 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Guidant Cardiac and Vascular Surgery devices

Submission Details

510(k) Number K003495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2000
Decision Date February 07, 2001
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 309
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K003495.
6F MACH 1, MODEL 34356-XXX
K010874 · Boston Scientific Corp · Jun 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · Cordis Corp. · Jun 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc. · Feb 2001
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · Medtronic Vascular · Aug 2000
CORDIS INTRODUCER GUIDE
K001136 · Cordis Corp. · Apr 2000
ENVOY AND VISTA BRITE TIP
K000715 · Cordis Corp. · Mar 2000