Cleared Traditional

SOFTOUCH GUIDING CATHETER (K902953) - FDA 510(k) Clearance

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

K902953 · Mallinckrodt Medical · Cardiovascular device
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Sep 1990
Decision
85d
Days
Class 2
Risk

K902953 is an FDA 510(k) clearance for the SOFTOUCH GUIDING 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 September 28, 1990 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

Submission Details

510(k) Number K902953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1990
Decision Date September 28, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K902953.
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · C.R. Bard, Inc. · Feb 1991
MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · C.R. Bard, Inc. · Apr 1990
SONICATH(TM) 5 F
K895542 · Boston Scientific Corp · Apr 1990
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990