Cleared Traditional

K842113 - AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT

K842113 is an FDA 510(k) clearance for AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT, manufactured by Mallinckrodt Critical Care. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 116-day FDA review.

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

FDA 510(k) Submission Details - K842113

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
Combination Product No
PCCP Authorized No
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.

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 84
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K842113.
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
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
CARDIAC CATHETERIZATION PACK
K840671 · Professional Medical Services · Mar 1984
VERTEX PERCUTANEOUS CATHETER INTRODUC
K840017 · Professional Medical Services · Feb 1984