Cleared Traditional

K072719 - CONVOY ADVANCED DELIVERY SHEATH

K072719 is an FDA 510(k) clearance for CONVOY ADVANCED DELIVERY SHEATH, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K072719

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.

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 595
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K072719.
DESTINATION RENAL GUIDING SHEATH
K081045 · Terumo Medical Corp. · May 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · Terumo Medical Corp. · May 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · Thomas Medical Products, Inc. · 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