Cleared Traditional

Performer Introducer (K173068) - FDA 510(k) Clearance

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

K173068 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
49d
Days
Class 2
Risk

K173068 is an FDA 510(k) clearance for the Performer Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on November 17, 2017 after a review of 49 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook Incorporated devices

Submission Details

510(k) Number K173068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date November 17, 2017
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 K173068.
AcQRef Introducer Sheath
K171557 · Acutus Medical, Inc. · Feb 2018
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 · Cook Incorporated · Dec 2017
Peel-Away Introducer Set
K173685 · Cook Incorporated · Dec 2017
Peel-Away Introducer Set
K170020 · Cook Incorporated · Sep 2017
Prelude Pursuit Splittable Sheath Introducer
K172117 · Merit Medical Systems, Inc. · Sep 2017
Liver Access and Biopsy Sets
K171853 · Cook Incorporated · Aug 2017