Cleared Traditional

K840240 - MICROFUSE INTRAVENOUS CATHETER SET

K840240 is the FDA 510(k) clearance for MICROFUSE INTRAVENOUS CATHETER SET by Norton Performance Plastics Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K840240 · Norton Performance Plastics Corp. · Cardiovascular device
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Apr 1984
Decision
88d
Days
Class 2
Risk

K840240 is an FDA 510(k) clearance for the MICROFUSE INTRAVENOUS CATHETER SET. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 88 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 Norton Performance Plastics Corp. devices

Submission Details

510(k) Number K840240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date April 17, 1984
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 581
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K840240.
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · Norton Performance Plastics Corp. · Jul 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · Gish Biomedical, Inc. · Jun 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · Advanced Cardiovascular Systems, Inc. · Mar 1984
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
K840336 · Arrow Intl., Inc. · Feb 1984
DOUBLE LUMEN INFUSION CATHETERS
K840175 · Medical Components, Inc. · Feb 1984