Cleared Traditional

K813143 - DESILET

K813143 is the FDA 510(k) clearance for DESILET by Exco, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K813143 · Exco, Inc. · Cardiovascular device
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Nov 1981
Decision
22d
Days
Class 2
Risk

K813143 is an FDA 510(k) clearance for the DESILET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Exco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 22 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 Exco, Inc. devices

Submission Details

510(k) Number K813143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1981
Decision Date November 27, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
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 331
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K813143.
ARGYLE INTRAMEDICUT CATHETER KIT
K821324 · Sherwood Medical Co. · Jul 1982
INTRODUCER SET
K821188 · Advanced Cardiovascular Systems, Inc. · Jul 1982
PERCOR PERCUTANEOUS INTRODUCER
K820834 · Datascope Corp. · Apr 1982
IMPLANTAID LEAD INTRODUCER #319-10 & 12
K812502 · Intermedics, Inc. · Oct 1981
INTK-08 8 FRENCH INTRODUCER KIT W/SIDE
K812325 · Sorensen Research · Sep 1981
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979