Cleared Traditional

K122958 - DELIVERY SHEATH

K122958 is an FDA 510(k) clearance for DELIVERY SHEATH, manufactured by Oscor, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K122958 · Oscor, Inc. · Cardiovascular device
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Dec 2012
Decision
79d
Days
Class 2
Risk

K122958 is an FDA 510(k) clearance for the DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY. 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 December 13, 2012 after a review of 79 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oscor, Inc. devices

FDA 510(k) Submission Details - K122958

510(k) Number K122958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date December 13, 2012
Days to Decision 79 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
46d faster than avg
Panel avg: 125d · This submission: 79d
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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122958.
EQUAFLOW MULTIVALVE INFUSION CATHETER
K123235 · Cook Incorporated · Feb 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K122431 · Thomas Medical Products, Inc. · Jan 2013
SUREFLEX STEERABLE GUIDING SHEATH KIT
K122926 · Baylis Medical Co., Inc. · Jan 2013
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
INTRODUCER SET, MODEL ADELANTE-S SERIES
K122084 · Oscor, Inc. · Aug 2012