GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle
by Creganna Medical Aslo Business AS Cregganna Tactx Medical
510(k) K152913
Active
Valid until
Not listed
FDA recalls
1 ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK152913 | Date21 Jul 2016 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Ongoing Z-2249-2023
Three lots of product may be labeled with an incorrect expiration day
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Gore Tips Set, Gore Tips Sheath, and Gore Tips Needle are intravascular devices designed for use in percutaneous coronary interventions. These components are intended to facilitate the delivery and positioning of guidewires, catheters, or other interventional tools within coronary arteries, reducing friction and improving maneuverability during procedures.
The Gore Tips Set is supplied as a sterile, single-use assembly comprising a sheath, needle, and associated components. It is intended for use in cardiac catheterization laboratories under aseptic conditions, adhering to standard sterile technique. The device is classified under product code DYB and has received FDA 510(k) clearance and MDD authorization. No MRI safety information is specified, and proper disposal or reprocessing instructions are not applicable due to its single-use nature.
Other devices from Creganna Medical Aslo Business AS Cregganna Tactx Medical
Questions
AI-generated answers, 18 Sep 2026
What is the Gore Tips Set primarily used for in a clinical setting?
The Gore Tips Set is designed for use in percutaneous coronary interventions, specifically to assist with the delivery and positioning of guidewires, catheters, or other interventional tools within coronary arteries. Its low-friction design helps improve maneuverability during procedures in cardiac catheterization labs.
Is the Gore Tips Set intended for reuse, or is it meant to be used only once?
The Gore Tips Set is explicitly labeled as a single-use device, meaning it is intended for one-time use only under aseptic conditions in a cardiac catheterization lab. Reuse or reprocessing is not applicable or recommended due to its single-use nature.
How is the Gore Tips Set supplied, and what sterility precautions should be taken?
The Gore Tips Set is supplied as a sterile assembly, including a sheath, needle, and associated components. Since it is intended for use in sterile environments like cardiac catheterization labs, standard sterile technique must be followed during handling and deployment to maintain aseptic conditions.
What regulatory pathways has the Gore Tips Set undergone, and which advisory committee was involved?
The Gore Tips Set has received FDA 510(k) clearance under the traditional review pathway, with a decision code of SESE (Substantially Equivalent). The product was reviewed by the Cardiovascular (CV) Advisory Committee, and the submission was filed under product code DYB.