Cleared Traditional

Micropuncture Pedal Access Set (K172980) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 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