Cleared Traditional

K182914 - MC3 Vascular Access Kit 21030

K182914 is the FDA 510(k) clearance for MC3 Vascular Access Kit 21030 by Mc3 Incorporated. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K182914 · Mc3 Incorporated · Cardiovascular device
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Oct 2018
Decision
11d
Days
Class 2
Risk

K182914 is an FDA 510(k) clearance for the MC3 Vascular Access Kit 21030. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Mc3 Incorporated (Dexter, US). The FDA issued a Cleared decision on October 29, 2018 after a review of 11 days - a notably fast clearance 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: 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 Mc3 Incorporated devices

Submission Details

510(k) Number K182914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2018
Decision Date October 29, 2018
Days to Decision 11 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRE Dilator, Vessel, For Percutaneous Catheterization

All 43
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K182914.
S-MAK XL
K190175 · Merit Medical Systems, Inc. · Apr 2019
ExpanSure Transseptal Dilation System
K182064 · Baylis Medical Company, Inc. · Mar 2019
Dilator Sets
K183036 · Cook Incorporated · Dec 2018
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013