Cleared Traditional

PERCUTANEOUS SHEATH INTRODUCER TRAY (K834074) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K834074.
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 1985
PEEL-AWAY INTRODUCER SET
K844693 · Quinton, Inc. · Mar 1985
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · Sherwood Medical Co. · Jul 1982
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979