Cleared Traditional

K884159 - SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT

K884159 is an FDA 510(k) clearance for SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE ..., manufactured by Mallinckroot, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K884159 · Mallinckroot, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
141d
Days
Class 2
Risk

K884159 is an FDA 510(k) clearance for the SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT. 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 February 22, 1989 after a review of 141 days - within the typical 510(k) review window.

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: 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 Mallinckroot, Inc. devices

FDA 510(k) Submission Details - K884159

510(k) Number K884159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1988
Decision Date February 22, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 599
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K884159.
PERCUTANEOUS INTRODUCER
K893658 · Medamicus, Inc. · Aug 1989
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · Argon Medical Corp. · May 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · Oscor Medical Corp. · Mar 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · Daig Corp. · Feb 1989
USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR
K884104 · C.R. Bard, Inc. · Dec 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · Argon Medical Corp. · Aug 1988