Cleared Traditional

K841317 - DESERET HEPARIN COATED FLOW DIRECTED

K841317 is the FDA 510(k) clearance for DESERET HEPARIN COATED FLOW DIRECTED by Parke-Davis Co.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K841317 · Parke-Davis Co. · Cardiovascular device
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Jun 1984
Decision
70d
Days
Class 2
Risk

K841317 is an FDA 510(k) clearance for the DESERET HEPARIN COATED FLOW DIRECTED. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Parke-Davis Co. devices

Submission Details

510(k) Number K841317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date June 11, 1984
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 41
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K841317.
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1985
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952 · C.R. Bard, Inc. · Aug 1985
MEDTRONIC MODEL 6404
K851948 · Medtronic Vascular · Jun 1985
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836 · Instrumentation Laboratory CO · Feb 1984
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · Sorensen Research · Sep 1983