Cleared Traditional

ANGIOGRAPHY NEEDLE W/WO CONNECTION (K840923) - FDA 510(k) Clearance

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

K840923 · Dlp, Inc. · Cardiovascular device
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Apr 1984
Decision
46d
Days
Class 2
Risk

K840923 is an FDA 510(k) clearance for the ANGIOGRAPHY NEEDLE W/WO CONNECTION. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Dlp, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 46 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 Dlp, Inc. devices

Submission Details

510(k) Number K840923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1984
Decision Date April 17, 1984
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
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 217
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K840923.
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 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