Cleared Traditional

K122960 - STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

K122960 is an FDA 510(k) clearance for STEERABLE GUIDING 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.

K122960 · Oscor, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
79d
Days
Class 2
Risk

K122960 is an FDA 510(k) clearance for the STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO. 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 - K122960

510(k) Number K122960 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 648
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K122960.
REPROCESSED STEERABLE INTRODUCER
K123334 · Stryker Sustainability Solutions, Inc. · Jan 2013
ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
K122854 · Arrow International (Subsidiary of Teleflex Inc.) · Jan 2013
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY
K122958 · Oscor, Inc. · Dec 2012
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ
K122980 · Terumo Medical Corporation · Dec 2012
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING
K121234 · W.L. Gore & Associates, Inc. · Nov 2012
PTFE SUPER SHEATH INTRODUCER
K120617 · Martech Medical Products · Nov 2012