Cleared Traditional

K022513 - MEDCOMP VASCU-SHEATH INTRODUCER SET

K022513 is an FDA 510(k) clearance for MEDCOMP VASCU-SHEATH INTRODUCER SET, manufactured by Medcomp. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K022513 · Medcomp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
87d
Days
Class 2
Risk

K022513 is an FDA 510(k) clearance for the MEDCOMP VASCU-SHEATH INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medcomp (Harleysville, US). The FDA issued a Cleared decision on October 25, 2002 after a review of 87 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 Medcomp devices

FDA 510(k) Submission Details - K022513

510(k) Number K022513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date October 25, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 497
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K022513.
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · Medamicus, Inc. · Apr 2003
CO-AXIAL INTRODUCER NEEDLE
K022634 · Promex, Inc. · Nov 2002
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · St Jude Medical · Oct 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · Micro Therapeutics, Inc. · Sep 2002
MODIFICATION TO MEDAMICUS AXIA RSN
K022689 · Medamicus, Inc. · Aug 2002
SHEATH ADAPTER, MODEL SA-09847
K021723 · Arrow Intl., Inc. · Aug 2002