Cleared Traditional

K812143 - INTRODUCER, PERCUTANEOUS

K812143 is an FDA 510(k) clearance for INTRODUCER, manufactured by Willson. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812143 · Willson · Cardiovascular device
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Aug 1981
Decision
21d
Days
Class 2
Risk

K812143 is an FDA 510(k) clearance for the INTRODUCER, PERCUTANEOUS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Willson (Walker, US). The FDA issued a Cleared decision on August 18, 1981 after a review of 21 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 Willson devices

FDA 510(k) Submission Details - K812143

510(k) Number K812143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1981
Decision Date August 18, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K812143.
DESILET
K813143 · Exco, Inc. · Nov 1981
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · Sorensen Research · Sep 1981
PERMANENT LEAD INTRADUCER
K800356 · Daig Corp. · May 1980
THERMODILUTION CATHETER INTRO. KIT
K800619 · Norton Performance Plastics Corp. · Apr 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · Norton Performance Plastics Corp. · Apr 1980