Cleared Traditional

K930479 - NYLEX CATHETERS

K930479 is an FDA 510(k) clearance for NYLEX CATHETERS, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K930479 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
82d
Days
Class 2
Risk

K930479 is an FDA 510(k) clearance for the NYLEX CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami Lakes, US). The FDA issued a Cleared decision on April 21, 1993 after a review of 82 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 Cordis Corp. devices

FDA 510(k) Submission Details - K930479

510(k) Number K930479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1993
Decision Date April 21, 1993
Days to Decision 82 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
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K930479.
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
BALT GUIDING CATHETER
K925632 · Target Therapeutics · Jun 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993
RETRIEVER 10
K921649 · Target Therapeutics · Mar 1993
MORSE(R) ANGIOGRAPHIC CATHETERS
K922552 · North American Instrument Corp. · Mar 1993
ANGIOGRAPHIC CATHETER -- MODIFICATION
K922101 · Interventional Therapeutics Corp. · Feb 1993