Cleared Traditional

SOFTTOUCH(R) GUIDING CATHETER (K912199) - FDA 510(k) Clearance

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

K912199 · Mallinckrodt Medical · Cardiovascular device
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Jul 1991
Decision
74d
Days
Class 2
Risk

K912199 is an FDA 510(k) clearance for the SOFTTOUCH(R) GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K912199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1991
Decision Date July 30, 1991
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 313
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K912199.
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374 · Cordis Corp. · Feb 1992
CORDIS SHUTTLE CATHETER
K915777 · Cordis Corp. · Feb 1992
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · Cordis Corp. · Sep 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · C.R. Bard, Inc. · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990