Cleared Special

K122084 - INTRODUCER SET

K122084 is an FDA 510(k) clearance for INTRODUCER SET, 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 44-day FDA review.

K122084 · Oscor, Inc. · Cardiovascular device
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Aug 2012
Decision
44d
Days
Class 2
Risk

K122084 is an FDA 510(k) clearance for the INTRODUCER SET, MODEL ADELANTE-S SERIES. 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 August 29, 2012 after a review of 44 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K122084

510(k) Number K122084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date August 29, 2012
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122084.
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · Oscor, Inc. · Dec 2012
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO
K122960 · Oscor, Inc. · Dec 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · W.L. Gore & Associates, Inc. · Nov 2012
EDWARDS PERCUTANEOUS SHEATH INTRODUCER
K121185 · Edwards Lifesciences, LLC · Aug 2012
PRELUDE 7F SHORT SHEATH INTRODUCER
K122190 · Merit Medical Systems, Inc. · Aug 2012
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
K120158 · Thomas Medical Products, Inc. · Aug 2012