Cleared Special

K132713 - NMI COAXIAL MICROINTRODUCER SET

K132713 is the FDA 510(k) clearance for NMI COAXIAL MICROINTRODUCER SET by Navilyst Medical, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K132713 · Navilyst Medical, Inc. · Cardiovascular device
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Sep 2013
Decision
28d
Days
Class 2
Risk

K132713 is an FDA 510(k) clearance for the NMI COAXIAL MICROINTRODUCER SET. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Navilyst Medical, Inc. devices

Submission Details

510(k) Number K132713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2013
Decision Date September 27, 2013
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K132713.
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K093554 · Edwards Lifesciences, LLC · Apr 2010