Cleared Traditional

K131079 - CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC

K131079 is an FDA 510(k) clearance for CREGANNA-TACTX STEERABLE SHEATH SET SYM..., manufactured by Creganna Medical Devices. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K131079 · Creganna Medical Devices · Cardiovascular device
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Aug 2013
Decision
106d
Days
Class 2
Risk

K131079 is an FDA 510(k) clearance for the CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Creganna Medical Devices (Northborough, US). The FDA issued a Cleared decision on August 1, 2013 after a review of 106 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Creganna Medical Devices devices

FDA 510(k) Submission Details - K131079

510(k) Number K131079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2013
Decision Date August 01, 2013
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
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 487
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K131079.
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
K132030 · Medtronic, Inc. · Sep 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
K130687 · Medical Components, Inc. · Aug 2013
EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013
VALVED TEARAWAY INTRODUCER GENERATION II
K124046 · Medical Components, Inc. · Jun 2013
SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING
K123990 · Medtronic Vascular · Apr 2013