Cleared Traditional

K853072 - CORON PRES MONITOR KIT MODEL 80 LEFT KI...

K853072 is the FDA 510(k) clearance for CORON PRES MONITOR KIT MODEL 80 LEFT KI... by Camino Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K853072 · Camino Laboratories, Inc. · Cardiovascular device
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Dec 1985
Decision
139d
Days
Class 2
Risk

K853072 is an FDA 510(k) clearance for the CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Camino Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 139 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 Camino Laboratories, Inc. devices

Submission Details

510(k) Number K853072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1985
Decision Date December 09, 1985
Days to Decision 139 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 125d · This submission: 139d
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 392
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K853072.
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · The Kendal Co. · Apr 1986
CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES
K855126 · Cordis Corp. · Feb 1986
MEDTRONIC PERMANENT LEAD INTRODUCER
K854559 · Medtronic Vascular · Dec 1985
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
K853100 · Cobe Laboratories, Inc. · Sep 1985
PTCA GUIDING CATHETER
K851947 · Cordis Corp. · Aug 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · Telectronics, Inc. · Jul 1985