Cleared Special

K171866 - Sentrant Introducer Sheath with Hydrophilic Coating (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K171866 · Medtronic Vascular, Inc. · Cardiovascular device
Dec 2017
Decision
181d
Days
Class 2
Risk

K171866 is an FDA 510(k) clearance for the Sentrant Introducer Sheath with Hydrophilic Coating. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medtronic Vascular, Inc. (Santa Rosa, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 181 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K171866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date December 20, 2017
Days to Decision 181 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 44
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