Cleared Traditional

SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER (K943739) - FDA 510(k) Clearance

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

K943739 · Mallinckrodt Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
105d
Days
Class 2
Risk

K943739 is an FDA 510(k) clearance for the SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 105 days - within the typical 510(k) review window.

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 Medical devices

Submission Details

510(k) Number K943739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1994
Decision Date November 15, 1994
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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 K943739.
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
0.035 IN. WISE WIRE
K942927 · Boston Scientific Corp · Jun 1995
HIGH PRESSURE TUBING
K941978 · Abbott Laboratories · Dec 1994
CARDIAC CATHETERIZATION KIT
K932141 · Abbott Laboratories · Sep 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939 · Cordis Corp. · Aug 1994
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994