Cleared Traditional

K170298 - Liberator Beacon Tip Locking Stylet

K170298 is an FDA 510(k) clearance for Liberator Beacon Tip Locking Stylet, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K170298 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2017
Decision
260d
Days
Class 2
Risk

K170298 is an FDA 510(k) clearance for the Liberator Beacon Tip Locking Stylet. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 18, 2017 after a review of 260 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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 - K170298

510(k) Number K170298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2017
Decision Date October 18, 2017
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 15
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K170298.
Arrow Stiffening Stylet
K220280 · Arrow International, LLC (A subsidiary of Teleflex, Inc.) · Aug 2022
Biotronik Stylets
K191469 · Biotronik, Inc. · Aug 2019
GaltTWS
K182660 · Galt Medical Corp. · May 2019
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · St Jude Medical · Apr 2009
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001