Cleared Traditional

MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE (K894445) - FDA 510(k) Clearance

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

K894445 · Mallinckroot, Inc. · Cardiovascular device
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Oct 1989
Decision
77d
Days
Class 2
Risk

K894445 is an FDA 510(k) clearance for the MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Mallinckroot, Inc. (St Louis, US). The FDA issued a Cleared decision on October 2, 1989 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Mallinckroot, Inc. devices

Submission Details

510(k) Number K894445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date October 02, 1989
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 313
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K894445.
HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS
K897041 · C.R. Bard, Inc. · Mar 1990
DUAL GUIDE INTRODUCER CATHETER
K895044 · Cook, Inc. · Feb 1990
MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM
K891121 · Boston Scientific Corp · Dec 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · Baxter Healthcare Corp · Aug 1989
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR
K884104 · C.R. Bard, Inc. · Dec 1988
ACS FUNNEL INTRODUCER
K875158 · Advanced Cardiovascular Systems, Inc. · May 1988