Cleared Special

K140307 - ENVOY GUIDING CATHETER

K140307 is an FDA 510(k) clearance for ENVOY 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 73-day FDA review.

K140307 · 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
73d
Days
Class 2
Risk

K140307 is an FDA 510(k) clearance for the ENVOY GUIDING CATHETER. 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 21, 2014 after a review of 73 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K140307

510(k) Number K140307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2014
Decision Date April 21, 2014
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 K140307.
WINGMAN EXTENDABLE TIP SUPPORT CATHETER
K141547 · Reflow Medical · Sep 2014
MIVI 6F GUIDE CATHETER
K140557 · Mivi, LLC · Sep 2014
ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB
K140080 · Codman & Shurtleff, Inc. · Apr 2014
ACUITY PRO LEAD DELIVERY SYSTEM
K132914 · Boston Scientific · Apr 2014
TOTAL ACROSS
K133539 · Medtronic Vascular · Mar 2014
SUREFIRE GUIDING CATHETER
K140034 · Surefire Medical, Inc. · Feb 2014
K140307 · ENVOY GUIDING CATHETER
Download PDF FDA Summary Codman & Shurtleff, I…