Cleared Special

K172394 - Steerable Guide Catheter

K172394 is an FDA 510(k) clearance for Steerable Guide Catheter, manufactured by Abbott Vascular. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 29-day FDA review.

K172394 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
29d
Days
Class 2
Risk

K172394 is an FDA 510(k) clearance for the Steerable Guide Catheter. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Abbott Vascular (Santa Clara, US). The FDA issued a Cleared decision on September 6, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Vascular devices

FDA 510(k) Submission Details - K172394

510(k) Number K172394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date September 06, 2017
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 29
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K172394.
Steerable Introducer 12F
K192422 · Freudenberg Medical, LLC · Oct 2019
MitraClip G4 Steerable Guide Catheter
K190167 · Abbott · May 2019
FlexCath Advance Steerable Sheath and Dilator
K183174 · Medtronic Cryocath, LP · Nov 2018
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · Hansen Medical, Inc. · Sep 2016
Steerable Guide Catheter
K161985 · Abbott Vascular · Aug 2016