Cleared Special

K140080 - ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB

K140080 is an FDA 510(k) clearance for ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 100-day FDA review.

K140080 · Codman & Shurtleff, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
100d
Days
Class 2
Risk

K140080 is an FDA 510(k) clearance for the ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, M.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on April 24, 2014 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K140080

510(k) Number K140080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2014
Decision Date April 24, 2014
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 878
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K140080.
SOFIA DISTAL ACCESS CATHETER
K142014 · MicroVention, Inc. · Oct 2014
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547 · Reflow Medical · Sep 2014
MIVI 6F GUIDE CATHETER
K140557 · Mivi, LLC · Sep 2014
ENVOY GUIDING CATHETER
K140307 · Codman & Shurtleff, Inc. · Apr 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · Boston Scientific · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
K140080 · ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
Download PDF FDA Summary Codman & Shurtleff, I…