Cleared Special

K090114 - MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S

K090114 is an FDA 510(k) clearance for MODIFICATION TO:INTRODUCER SETS, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 134-day FDA review.

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

FDA 510(k) Submission Details - K090114

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

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 648
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