Cleared Traditional Expedited

K032587 - EDWARDS PERIPHERAL DILATATION CATHETER

K032587 is an FDA 510(k) clearance for EDWARDS PERIPHERAL DILATATION CATHETER, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K032587 · Edwards Lifesciences, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
41d
Days
Class 2
Risk

K032587 is an FDA 510(k) clearance for the EDWARDS PERIPHERAL DILATATION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on October 2, 2003 after a review of 41 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 Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K032587

510(k) Number K032587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2003
Decision Date October 02, 2003
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K032587.
PHERON PTA CATHETER
K033217 · Biotronik, Inc. · Oct 2003
PTA BALLOON CATHETER
K032931 · Cook, Inc. · Oct 2003
ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K032312 · Medtronic Vascular · Oct 2003
NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
K032591 · NuMED, Inc. · Sep 2003
EDWARDS DIRECTIONAL CATHETER
K030630 · Edwards Lifesciences, LLC · Sep 2003
ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
K032622 · Medtronic Vascular · Sep 2003