Cleared Traditional

K043084 - PREMERE DELIVERY SHEATH, MODEL PDS

K043084 is an FDA 510(k) clearance for PREMERE DELIVERY SHEATH, manufactured by Velocimed, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K043084 · Velocimed, Inc. · Cardiovascular device
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May 2005
Decision
175d
Days
Class 2
Risk

K043084 is an FDA 510(k) clearance for the PREMERE DELIVERY SHEATH, MODEL PDS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Velocimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on May 2, 2005 after a review of 175 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 Velocimed, Inc. devices

FDA 510(k) Submission Details - K043084

510(k) Number K043084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date May 02, 2005
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 125d · This submission: 175d
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 522
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K043084.
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · Applied Medical Resources Corp. · Oct 2004
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004