Cleared Traditional

K032869 - COOK CODA BALLOON CATHETER

K032869 is an FDA 510(k) clearance for COOK CODA BALLOON CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K032869 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
65d
Days
Class 2
Risk

K032869 is an FDA 510(k) clearance for the COOK CODA BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on November 19, 2003 after a review of 65 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.

FDA 510(k) Submission Details - K032869

510(k) Number K032869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2003
Decision Date November 19, 2003
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
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 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K032869.
POLARCATH PERIPHERAL DILATATION SYSTEM
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MEDTRONIC SELECTSITE DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59 AND C304-L69
K033989 · Medtronic Inc. Cardiac Rhythm Management · Jan 2004
BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER
K033441 · Boston Scientific Corp · Nov 2003
SCOUT PRO
K033320 · Biotronik, Inc. · Nov 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
K032784 · Intra Luminal Therapeutics, Inc. · Nov 2003
PHERON PTA CATHETER
K033217 · Biotronik, Inc. · Oct 2003
K032869 · COOK CODA BALLOON CATHETER
Download PDF FDA Summary Cook, Inc.