Cleared Traditional

K842259 - PCI W/CATH-SEAL SIDE FLOW FITTING

K842259 is the FDA 510(k) clearance for PCI W/CATH-SEAL SIDE FLOW FITTING by Universal Medical Instrument Corp.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K842259 · Universal Medical Instrument Corp. · Cardiovascular device
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Aug 1984
Decision
55d
Days
Class 2
Risk

K842259 is an FDA 510(k) clearance for the PCI W/CATH-SEAL SIDE FLOW FITTING. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Walker, US). The FDA issued a Cleared decision on August 1, 1984 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K842259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1984
Decision Date August 01, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 393
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K842259.
TELEFLEX MEDICAL INTRODUCER CATHETER
K851141 · Teleflexmedical, Inc. · May 1985
PEEL-AWAY INTRODUCER SET
K844693 · Quinton, Inc. · Mar 1985
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
EMERGENCY INFUSION DEVICE
K840455 · Arrow Intl., Inc. · May 1984
ANGIOGRAPHY NEEDLE W/WO CONNECTION
K840923 · Dlp, Inc. · Apr 1984
LEAD INTRODUCER SETS-EB-S8 & EB-S12
K831751 · Oscor, Inc. · Oct 1983