GORE® Tri-Lobe Balloon Catheter
FDA 510(k) K250410 · W. L. Gore & Associates, Inc.
510(k) numberK250410
Submission
- Device name
- GORE® Tri-Lobe Balloon Catheter
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- February 13, 2025
- Decision date
- June 2, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
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| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
| K163217 | GORE BIO-A Tissue ReinforcementOXF · Traditional | 02/10/2017SE |
Questions and answers
When was GORE® Tri-Lobe Balloon Catheter cleared by the FDA?
GORE® Tri-Lobe Balloon Catheter (K250410) received a 510(k) decision of Substantially Equivalent on June 2, 2025, 109 days after the submission was received.
What is the product code of K250410?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.