Cleared Traditional

K172635 - High-Flo Silver Polyethylene Catheter

K172635 is an FDA 510(k) clearance for High-Flo Silver Polyethylene Catheter, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K172635 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
214d
Days
Class 2
Risk

K172635 is an FDA 510(k) clearance for the High-Flo Silver Polyethylene Catheter. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 3, 2018 after a review of 214 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 - K172635

510(k) Number K172635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date April 03, 2018
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 338
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K172635.
Royal Flush Plus High-Flow Catheter
K180054 · Cook Incorporated · Oct 2018
4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters
K181836 · Cordis, A Cardinal Health Company · Aug 2018
AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
K173762 · AngioDynamics, Inc. · Jul 2018
Surefire Spark Infusion System
K180677 · Surefire Medical, Inc. · Apr 2018
SeQure® NF and SeQure® Microcatheters
K173430 · Accurate Medical Therapeutics, Ltd. · Jan 2018
Royal Flush Catheter
K171264 · Cook Incorporated · Jan 2018