Cleared Traditional

K860204 - ANGIOMAT 6000

K860204 is the FDA 510(k) clearance for ANGIOMAT 6000 by Mallinckrodt Group, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K860204 · Mallinckrodt Group, Inc. · Cardiovascular device
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May 1986
Decision
100d
Days
Class 2
Risk

K860204 is an FDA 510(k) clearance for the ANGIOMAT 6000. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 100 days - within the typical 510(k) review window.

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: 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 Group, Inc. devices

Submission Details

510(k) Number K860204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date May 02, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K860204.
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY
K863537 · Cordis Corp. · Oct 1986
USCI (R) DISPOSABLE INFLATION DEVICE
K863037 · C.R. Bard, Inc. · Sep 1986
MECHANICAL INFLATION DEVICE
K862547 · American Edwards Laboratories · Sep 1986
ANGIOJECT
K860842 · Target Therapeutics · Apr 1986
ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE
K850861 · Medical Components, Inc. · Feb 1986
ACS INDEFLATOR (MODIFICATION)
K854310 · Advanced Cardiovascular Systems, Inc. · Dec 1985