Cleared Traditional

K021004 - VALVED PEELABLE INTRODUCER

K021004 is an FDA 510(k) clearance for VALVED PEELABLE INTRODUCER, manufactured by Medamicus, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K021004 · Medamicus, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
70d
Days
Class 2
Risk

K021004 is an FDA 510(k) clearance for the VALVED PEELABLE INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 6, 2002 after a review of 70 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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K021004

510(k) Number K021004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date June 06, 2002
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
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 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K021004.
SHEATH ADAPTER, MODEL SA-09847
K021723 · Arrow Intl., Inc. · Aug 2002
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc. · Jul 2002
BD INTROSYTE PRECISION INTRODUCER
K020834 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · Edwards Lifesciences, LLC · Mar 2002
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp. · Nov 2001
CAROTID GUIDING SHEATH
K012812 · Terumo Medical Corp. · Nov 2001