Cleared Traditional

K171609 - Check-Flo Performer Introducer Micropun...

K171609 is an FDA 510(k) clearance for Check-Flo Performer Introducer Micropun..., manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K171609 · Cook Incorporated · Cardiovascular device
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Jun 2018
Decision
368d
Days
Class 2
Risk

K171609 is an FDA 510(k) clearance for the Check-Flo Performer Introducer Micropuncture Radial Artery Access Set. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 4, 2018 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook Incorporated devices

FDA 510(k) Submission Details - K171609

510(k) Number K171609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2017
Decision Date June 04, 2018
Days to Decision 368 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
243d slower than avg
Panel avg: 125d · This submission: 368d
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 461
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K171609.
Glidesheath Slender Tibial Pedal Kit
K181237 · Terumo Medical Corporation · Aug 2018
RadialSeal Introducer Kit
K181855 · Great Batch Medical · Jul 2018
iSLEEVE Introducer Set
K180785 · Boston Scientific Corporation · Jun 2018
VSI Micro-Introducer Kit
K180913 · Vascular Solutions, Inc. · May 2018
Glidesheath Slender
K173831 · Terumo Medical Corporation · May 2018
Micropuncture Pedal Access Set
K172980 · Cook Incorporated · May 2018