Cleared Traditional

K072719 - CONVOY ADVANCED DELIVERY SHEATH

K072719 is the FDA 510(k) clearance for CONVOY ADVANCED DELIVERY SHEATH by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K072719 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
164d
Days
Class 2
Risk

K072719 is an FDA 510(k) clearance for the CONVOY ADVANCED DELIVERY SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on March 7, 2008 after a review of 164 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K072719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2007
Decision Date March 07, 2008
Days to Decision 164 days
Submission Type Traditional
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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 390
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K072719.
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K082356 · W.L. Gore & Associates, Inc. · Aug 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · Terumo Medical Corp. · May 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp. · Mar 2008
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · Oscor, Inc. · Nov 2007
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · Applied Medical Resources Corp. · Sep 2007