Cleared Traditional

DIAGNOSTIC INTRAVASCULAR CATHETERS (K853182) - FDA 510(k) Clearance

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

K853182 · Mallinckrodt Critical Care · Cardiovascular device
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Jan 1986
Decision
169d
Days
Class 2
Risk

K853182 is an FDA 510(k) clearance for the DIAGNOSTIC INTRAVASCULAR CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (St Louis, US). The FDA issued a Cleared decision on January 15, 1986 after a review of 169 days - an extended review 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: 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 K853182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date January 15, 1986
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
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 153
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K853182.
SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK
K862465 · Shiley, Inc. · Aug 1986
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH
K862006 · Cordis Corp. · Jun 1986
MODIFIED CORDIS PTCA GUIDING CATHETERS
K854576 · Cordis Corp. · Feb 1986
PTCA GUIDING CATHER
K844161 · Cordis Corp. · Jan 1985
VARIOUS CARDIOVASCULAR PRODUCTS
K823357 · C.R. Bard, Inc. · Mar 1983
USCI CARDIOVASCULAR CATHETER
K810412 · C.R. Bard, Inc. · Mar 1981