Cleared Traditional

K162389 - Medcomp Vessel Dilator

K162389 is the FDA 510(k) clearance for Medcomp Vessel Dilator by Medcomp ( Medical Components). It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K162389 · Medcomp ( Medical Components) · Cardiovascular device
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Jun 2017
Decision
279d
Days
Class 2
Risk

K162389 is an FDA 510(k) clearance for the Medcomp Vessel Dilator. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Medcomp ( Medical Components) (Harleysville, US). The FDA issued a Cleared decision on June 1, 2017 after a review of 279 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Medcomp ( Medical Components) devices

Submission Details

510(k) Number K162389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2016
Decision Date June 01, 2017
Days to Decision 279 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
154d slower than avg
Panel avg: 125d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 37
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K162389.
ExpanSure Transseptal Dilation System
K182064 · Baylis Medical Company, Inc. · Mar 2019
Dilator Sets
K183036 · Cook Incorporated · Dec 2018
MC3 Vascular Access Kit 21030
K182914 · Mc3 Incorporated · Oct 2018
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013