Cleared Traditional

K844840 - DESERET INTRODUCER SET

K844840 is the FDA 510(k) clearance for DESERET INTRODUCER SET by Parke-Davis Co.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K844840 · Parke-Davis Co. · Cardiovascular device
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May 1985
Decision
155d
Days
Class 2
Risk

K844840 is an FDA 510(k) clearance for the DESERET INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Parke-Davis Co. (Rochester, US). The FDA issued a Cleared decision on May 16, 1985 after a review of 155 days - an extended review 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: 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 Parke-Davis Co. devices

Submission Details

510(k) Number K844840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1984
Decision Date May 16, 1985
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 325
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K844840.
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · Telectronics, Inc. · Jul 1985
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · Telectronics, Inc. · Jul 1985
PERCUTANEOUS ANGIOGRAPHIC NEEDLES
K845037 · Mallinckrodt Critical Care · Jun 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