Cleared Traditional

K162097 - InTRAkit

K162097 is an FDA 510(k) clearance for InTRAkit, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K162097 · Medtronic Vascular · Cardiovascular device
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Nov 2016
Decision
111d
Days
Class 2
Risk

K162097 is an FDA 510(k) clearance for the InTRAkit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on November 17, 2016 after a review of 111 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K162097

510(k) Number K162097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2016
Decision Date November 17, 2016
Days to Decision 111 days
Submission Type Traditional
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
14d faster than avg
Panel avg: 125d · This submission: 111d
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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K162097.
Flextra Steerable Introducer
K170373 · Rhythm Xience, Inc. (Rxi) · Feb 2017
FlexCath Select Steerable Shealth and Dilator
K163268 · Medtronic Cryocath, LP · Feb 2017
Vado Bi-Directional Steerable Sheath
K162427 · Kalila Medical, Inc. · Jan 2017
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
K162322 · Access Scientific, LLC · Nov 2016
Pinpoint GT Introducer Needle
K162769 · C.R. Bard, Inc. · Nov 2016
TXM Guiding Sheath
K153771 · Texasmedical Technologies, Inc. · Sep 2016