Cleared Traditional

K860161 - HEART CATHETERIZATION TRAY

K860161 is an FDA 510(k) clearance for HEART CATHETERIZATION TRAY, manufactured by Medical Design Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K860161 · Medical Design Concepts, Inc. · Cardiovascular device
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May 1986
Decision
106d
Days
Class 2
Risk

K860161 is an FDA 510(k) clearance for the HEART CATHETERIZATION TRAY. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Medical Design Concepts, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Medical Design Concepts, Inc. devices

FDA 510(k) Submission Details - K860161

510(k) Number K860161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1986
Decision Date May 02, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 87
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K860161.
10 AND 12 FRENCH VESSEL DILATORS
K874738 · Impra, Inc. · May 1988
URESIL CAROTID ARTERY SIZERS
K871148 · Uresil Corp. · Apr 1987
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · Mallinckrodt Critical Care · Jul 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
CARDIAC CATHETERIZATION PACK
K840671 · Professional Medical Services · Mar 1984