Cleared Traditional

K963071 - ANGIOMAT ILLUMENA

K963071 is an FDA 510(k) clearance for ANGIOMAT ILLUMENA, manufactured by Mallinckrodt Inc., Liebel-Flarsheim Business. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K963071 · Mallinckrodt Inc., Liebel-Flarsheim Business · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1997
Decision
412d
Days
Class 2
Risk

K963071 is an FDA 510(k) clearance for the ANGIOMAT ILLUMENA. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Inc., Liebel-Flarsheim Business (Cincinnati, US). The FDA issued a Cleared decision on September 23, 1997 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Mallinckrodt Inc., Liebel-Flarsheim Business devices

FDA 510(k) Submission Details - K963071

510(k) Number K963071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1996
Decision Date September 23, 1997
Days to Decision 412 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
287d slower than avg
Panel avg: 125d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 129
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K963071.
OZ POWER SYRINGE
K973334 · Cardiovascular Innovations · Apr 1998
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · Coeur Laboratories, Inc. · Oct 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · Contour Fabricators of Florida, Inc. · Oct 1996