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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 695
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K043084.
INNER-LOCK INTRODUCER SHEATH
K051468 · Rex Medical · Aug 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
K051096 · St. Jude Medical, Daig Division, Inc. · May 2005
SECURELOC
K050023 · Specialized Health Products, Inc. · Feb 2005
SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018
K042308 · Facile Medical, Inc. · Feb 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
K043084 · PREMERE DELIVERY SHEATH, MODEL PDS
Download PDF FDA Summary Velocimed, Inc.