510(k) K180919
K180919 is an FDA 510(k) premarket notification submitted by W. L. Gore and Associates, Inc. for the device "GORE Tri-Lumen Catheter". The FDA issued a decision of Substantially Equivalent on October 5, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. W. L. Gore and Associates, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2018
- Date Received
- April 9, 2018
- 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