Cleared Traditional

K172980 - Micropuncture Pedal Access Set

K172980 is an FDA 510(k) clearance for Micropuncture Pedal Access Set, 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 218-day FDA review.

K172980 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
218d
Days
Class 2
Risk

K172980 is an FDA 510(k) clearance for the Micropuncture Pedal 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 May 3, 2018 after a review of 218 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. 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 Cook Incorporated devices

FDA 510(k) Submission Details - K172980

510(k) Number K172980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date May 03, 2018
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 K172980.
Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
K171609 · Cook Incorporated · Jun 2018
VSI Micro-Introducer Kit
K180913 · Vascular Solutions, Inc. · May 2018
Glidesheath Slender
K173831 · Terumo Medical Corporation · May 2018
RAILWAY Sheathless Access System
K180081 · Cordis Corporation · Apr 2018
Performer Guiding Sheath
K171988 · Cook Incorporated · Mar 2018
Transjugular Liver Access Sets
K171820 · Cook Incorporated · Mar 2018