Cleared Traditional

K831509 - ANGIOGRAPHY KIT W/ADDIT. COMPONENTS

K831509 is the FDA 510(k) clearance for ANGIOGRAPHY KIT W/ADDIT. COMPONENTS by Mallinckrodt Critical Care. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K831509 · Mallinckrodt Critical Care · Cardiovascular device
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Jun 1983
Decision
28d
Days
Class 2
Risk

K831509 is an FDA 510(k) clearance for the ANGIOGRAPHY KIT W/ADDIT. COMPONENTS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K831509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date June 08, 1983
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 304
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K831509.
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
COMPRESSAR DISPOSABLE DISC
K831337 · Instromedix, Inc. · Jul 1983
ANGIOGRAPHIC NEEDLE
K831189 · Medrad, Inc. · May 1983
CENTRAL VEIN CATHERIZATION KIT-14-690-
K830788 · Norton Performance Plastics Corp. · Apr 1983
DIAGNOSTIC INTRAVASCULAR CATHETER
K830415 · Mallinckrodt Critical Care · Apr 1983