Cleared Special

K070159 - PRELUDE SHEATH INTRODUCER

K070159 is an FDA 510(k) clearance for PRELUDE SHEATH INTRODUCER, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Special 510(k) pathway after a 155-day FDA review.

K070159 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
155d
Days
Class 2
Risk

K070159 is an FDA 510(k) clearance for the PRELUDE SHEATH INTRODUCER. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on June 21, 2007 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K070159

510(k) Number K070159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2007
Decision Date June 21, 2007
Days to Decision 155 days
Submission Type Special
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
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Modification to existing cleared device.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 103
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K070159.
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · Merit Medical Systems, Inc. · Nov 2007
GALTSTICK INTRODUCER SYSTEM
K071330 · Galt Medical Corp. · Oct 2007
ESTECH PERCUTANEOUS INSERTION DILATOR KIT
K070749 · Coombs Medical Device Consulting · Oct 2007
STARCLOSE HEX-HUB DILATOR
K062554 · Abbott Vascular, Inc. · Feb 2007
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
K061000 · Cook Vascular, Inc. · May 2006
SUPER SHEATH INTRODUCER SHEATH
K052557 · Togo Medikit Co., Ltd. · Jan 2006
K070159 · PRELUDE SHEATH INTRODUCER
Download PDF FDA Summary Merit Medical Systems…