Cleared Traditional

K823920 - COEURLOCK STERILE DISPOS. ANGIOGRAPHIC

K823920 is an FDA 510(k) clearance for COEURLOCK STERILE DISPOS. ANGIOGRAPHIC, manufactured by Coeur Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K823920 · Coeur Laboratories, Inc. · Cardiovascular device
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Feb 1983
Decision
52d
Days
Class 2
Risk

K823920 is an FDA 510(k) clearance for the COEURLOCK STERILE DISPOS. ANGIOGRAPHIC. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Coeur Laboratories, Inc.. The FDA issued a Cleared decision on February 18, 1983 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Coeur Laboratories, Inc. devices

FDA 510(k) Submission Details - K823920

510(k) Number K823920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1982
Decision Date February 18, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 170
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K823920.
ANGIOGRAPHIC DRAPE PACKS
K840281 · Medrad, Inc. · Apr 1984
ANGIOPLASTY INFLATION DEVICE & CARTR
K834107 · Cordis Corp. · Jan 1984
DIGITAL INJECTOR SYS
K833138 · Sybron Corp. · Nov 1983
BACKSTOP VALVE W/SIDE ARM
K823190 · Vertex Medical Corp. · Dec 1982
DISPOSABLE PLASTIC STOPCOCK
K823191 · Vertex Medical Corp. · Dec 1982
TUOHY-BORST ADAPTER W/SIDE ARM
K823192 · Vertex Medical Corp. · Dec 1982