510(k) K261418
K261418 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Liquick X-treme, Liquick X-treme Plus". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code EZD (Catheter, Straight), a Class II device regulated under 21 CFR 876.5130. Teleflex Medical has 42 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2026
- Date Received
- Apr 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Straight
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type
- 510(k)