Cleared Traditional

K834074 - PERCUTANEOUS SHEATH INTRODUCER TRAY

K834074 is an FDA 510(k) clearance for PERCUTANEOUS SHEATH INTRODUCER TRAY, manufactured by Packaging Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K834074 · Packaging Technologies, Inc. · Cardiovascular device
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Mar 1984
Decision
115d
Days
Class 2
Risk

K834074 is an FDA 510(k) clearance for the PERCUTANEOUS SHEATH INTRODUCER TRAY. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Packaging Technologies, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Packaging Technologies, Inc. devices

FDA 510(k) Submission Details - K834074

510(k) Number K834074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date March 19, 1984
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 639
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K834074.
PERCUTANEOUS CATHETER INTRODUCER SET
K842004 · Aries Medical, Inc. · Jul 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
FRENCH PERCUTANEOUS SHEATH INTRODUCER
K830813 · Norton Performance Plastics Corp. · Apr 1983
CORONARY GUIDING CATHETER
K830829 · Advanced Cardiovascular Systems, Inc. · Apr 1983