Cleared Traditional

van Andel Dilatation Catheter (K170616) - FDA 510(k) Clearance

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

K170616 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
58d
Days
Class 2
Risk

K170616 is an FDA 510(k) clearance for the van Andel Dilatation Catheter. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 28, 2017 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 K170616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2017
Decision Date April 28, 2017
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 35
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K170616.
ExpanSure Transseptal Dilation System
K182064 · Baylis Medical Company, Inc. · Mar 2019
Dilator Sets
K183036 · Cook Incorporated · Dec 2018
MC3 Vascular Access Kit 21030
K182914 · Mc3 Incorporated · Oct 2018
VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013
RETROFLEX DILATOR KIT
K093554 · Edwards Lifesciences, LLC · Apr 2010