Cleared Special

K034061 - MODIFICATION TO CONVOY ADVANCED DELIVER...

K034061 is the FDA 510(k) clearance for MODIFICATION TO CONVOY ADVANCED DELIVER... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Special 510(k) pathway after a 30-day FDA review.

K034061 · Boston Scientific Corp · Cardiovascular device
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Jan 2004
Decision
30d
Days
Class 2
Risk

K034061 is an FDA 510(k) clearance for the MODIFICATION TO 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 January 30, 2004 after a review of 30 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 Boston Scientific Corp devices

Submission Details

510(k) Number K034061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2003
Decision Date January 30, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K034061.
AIRGUARD VALVED INTRODUCER
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INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · B.Braun Medical, Inc. · Feb 2004
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · Merit Medical Systems, Inc. · Oct 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · St Jude Medical · Jul 2003