Cleared Traditional

K834459 - DIAGNOSTIC RADIOLOGY CATHETERS

K834459 is the FDA 510(k) clearance for DIAGNOSTIC RADIOLOGY CATHETERS by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K834459 · American Edwards Laboratories · Cardiovascular device
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Feb 1984
Decision
47d
Days
Class 2
Risk

K834459 is an FDA 510(k) clearance for the DIAGNOSTIC RADIOLOGY CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 American Edwards Laboratories devices

Submission Details

510(k) Number K834459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date February 04, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 125d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K834459.
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · American Edwards Laboratories · Aug 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · Advanced Cardiovascular Systems, Inc. · Jul 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · Electro-Catheter Corp. · Jun 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · Mallinckrodt Critical Care · Jun 1983
ANGIOGRAPHIC NEEDLE
K831189 · Medrad, Inc. · May 1983