Cleared Special

MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S (K090114) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K090114 · Oscor, Inc. · Cardiovascular device
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Jun 2009
Decision
134d
Days
Class 2
Risk

K090114 is an FDA 510(k) clearance for the MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 4, 2009 after a review of 134 days - within the typical 510(k) review window.

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. 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.

View all Oscor, Inc. devices

Submission Details

510(k) Number K090114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date June 04, 2009
Days to Decision 134 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
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 282
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K090114.
GLIDESHEATH
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GORE DRYSEAL SHEATH
K093791 · W.L. Gore & Associates, Inc. · Mar 2010
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · Terumo Medical Corp. · May 2009
PINNACLE ROII INTRODUCER SHEATH
K082847 · Terumo Medical Corp. · Oct 2008
PRELUDE SHORT SHEATH INTRODUCER
K082063 · Merit Medical Systems, Inc. · Oct 2008