Cleared Special

K140015 - CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER

K140015 is an FDA 510(k) clearance for CARDIOSOLUTIONS DEXTERITY STEERABLE INT..., manufactured by Cardiosolutions, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 34-day FDA review.

K140015 · Cardiosolutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
34d
Days
Class 2
Risk

K140015 is an FDA 510(k) clearance for the CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardiosolutions, Inc. (West Bridgewater, US). The FDA issued a Cleared decision on February 5, 2014 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Cardiosolutions, Inc. devices

FDA 510(k) Submission Details - K140015

510(k) Number K140015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2014
Decision Date February 05, 2014
Days to Decision 34 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 485
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K140015.
CATHETER INTRODUCER SHEATH
K131627 · Edwards Lifesciences, LLC · Mar 2014
INTRODUCER SETS, MODEL ADELANTE RADIAL
K130633 · Oscor, Inc. · Feb 2014
HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH
K132720 · Merit Medical Systems, Inc. · Feb 2014
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013