Cleared Traditional

K022634 - CO-AXIAL INTRODUCER NEEDLE

K022634 is an FDA 510(k) clearance for CO-AXIAL INTRODUCER NEEDLE, manufactured by Promex, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022634 · Promex, Inc. · Cardiovascular device
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Nov 2002
Decision
90d
Days
Class 2
Risk

K022634 is an FDA 510(k) clearance for the CO-AXIAL INTRODUCER NEEDLE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on November 6, 2002 after a review of 90 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 Promex, Inc. devices

FDA 510(k) Submission Details - K022634

510(k) Number K022634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2002
Decision Date November 06, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 409
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K022634.
SAFETY INTRODUCER NEEDLE
K030135 · B.Braun Medical, Inc. · Jul 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · Edwards Lifesciences, LLC · Jun 2003
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003
MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
K023447 · St Jude Medical · Oct 2002
MEDCOMP VASCU-SHEATH INTRODUCER SET
K022513 · Medcomp · Oct 2002
TITAN MICRO CATHETER, MODEL 105-5074-153
K022003 · Micro Therapeutics, Inc. · Sep 2002