Cleared Special

Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design (K171275) - FDA 510(k) Clearance

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

K171275 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
233d
Days
Class 2
Risk

K171275 is an FDA 510(k) clearance for the Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Des.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 20, 2017 after a review of 233 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.

View all Cook Incorporated devices

Submission Details

510(k) Number K171275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 01, 2017
Decision Date December 20, 2017
Days to Decision 233 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
108d slower than avg
Panel avg: 125d · This submission: 233d
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 312
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K171275.
Type I, Type II, Type III, Type IV
K172331 · Lepu Medical Technology (Beijing) Co., Ltd. · Mar 2018
Prelude IDeal Hydrophilic Sheath Introducer
K173750 · Merit Medical Systems, Inc. · Feb 2018
AcQRef Introducer Sheath
K171557 · Acutus Medical, Inc. · Feb 2018
Peel-Away Introducer Set
K173685 · Cook Incorporated · Dec 2017
Performer Introducer
K173068 · Cook Incorporated · Nov 2017
Peel-Away Introducer Set
K170020 · Cook Incorporated · Sep 2017