Cleared Traditional

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set (K171609) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 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