Cleared Traditional

K931479 - SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER

K931479 is an FDA 510(k) clearance for SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER, manufactured by Mallinckrodt Medical. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K931479 · Mallinckrodt Medical · Cardiovascular device
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Oct 1993
Decision
196d
Days
Class 2
Risk

K931479 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 October 6, 1993 after a review of 196 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 Medical devices

FDA 510(k) Submission Details - K931479

510(k) Number K931479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date October 06, 1993
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 413
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K931479.
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654 · Scimed Life Systems, Inc. · Feb 1994
CARAPACE ANGIOGRAPHY TRAYS
K931629 · Carapace, Inc. · Dec 1993
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K932218 · Associated Medical Products Co. · Aug 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · Scimed Life Systems, Inc. · Aug 1993
ANGIOGRAPHIC CATHETER
K926243 · Target Therapeutics · Aug 1993