Cleared Traditional

ACUITY STEERABLE STYLET ACCESSORY (K053019) - FDA 510(k) Clearance

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

K053019 · Guidant Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
128d
Days
Class 2
Risk

K053019 is an FDA 510(k) clearance for the ACUITY STEERABLE STYLET ACCESSORY. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Guidant Corporation (St Paul, US). The FDA issued a Cleared decision on March 3, 2006 after a review of 128 days - within the typical 510(k) review window.

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 Guidant Corporation devices

Submission Details

510(k) Number K053019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2005
Decision Date March 03, 2006
Days to Decision 128 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 125d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 27
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K053019.
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
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated · Oct 2017
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001