Cleared Special

K161985 - Steerable Guide Catheter

K161985 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 19-day FDA review.

K161985 · Abbott Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
19d
Days
Class 2
Risk

K161985 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 August 7, 2016 after a review of 19 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 - K161985

510(k) Number K161985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2016
Decision Date August 07, 2016
Days to Decision 19 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
106d faster than avg
Panel avg: 125d · This submission: 19d
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 20
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K161985.
FlexCath Advance Steerable Sheath and Dilator
K183174 · Medtronic Cryocath, LP · Nov 2018
Steerable Guide Catheter
K172394 · Abbott Vascular · Sep 2017
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005