Cleared Traditional

K152913 - GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

K152913 is an FDA 510(k) clearance for GORE TIPS Set, manufactured by Creganna Medical Aslo Business AS Cregganna Tactx Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K152913 · Creganna Medical Aslo Business AS Cregganna Tactx Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
293d
Days
Class 2
Risk

K152913 is an FDA 510(k) clearance for the GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Creganna Medical Aslo Business AS Cregganna Tactx Medical (Galway, IE). The FDA issued a Cleared decision on July 21, 2016 after a review of 293 days - an extended review 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: 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 - K152913

510(k) Number K152913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2015
Decision Date July 21, 2016
Days to Decision 293 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
168d slower than avg
Panel avg: 125d · This submission: 293d
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 Consultant

W. L. Gore & Associates, Inc.
Kaitlin Grove

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K152913.
TXM Guiding Sheath
K153771 · Texasmedical Technologies, Inc. · Sep 2016
Edwards eSheath Introducer Set
K162184 · Edward Lifesciences · Sep 2016
HQS Introducer (Model 2064-HQS)
K153494 · Alseal · Aug 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · Libramedical, Inc. · Jul 2016
Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
K153533 · Galt Medical Corp. · Jul 2016
Halo One Thin-Walled Guiding Sheath
K161183 · C.R. Bard, Inc. · Jun 2016