Cleared Traditional

AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT (K842113) - FDA 510(k) Clearance

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

K842113 · Mallinckrodt Critical Care · Cardiovascular device
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Jul 1984
Decision
116d
Days
Class 2
Risk

K842113 is an FDA 510(k) clearance for the AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 116 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K842113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date July 13, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 31
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K842113.
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · Cordis Corp. · Apr 1997
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · Quinton, Inc. · Dec 1983