510(k) K250410
K250410 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE® Tri-Lobe Balloon Catheter". The FDA issued a decision of Substantially Equivalent on June 2, 2025. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2025
- Date Received
- February 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type