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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 667
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K131079.
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PTFE SUPER SHEATH INTRODUCER
K130855 · Martech Medical Products · Jul 2013
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K123714 · Edwards Lifesciences, LLC · Jul 2013
CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER
K131332 · Cardiosolutions, Inc. · Jul 2013
K131079 · CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
Download PDF FDA Summary Creganna Medical Devi…