510(k) clearance
Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler
- 510(k) number
- K260080
- Applicant
- Medical Components, Inc.
- Decision date
- Oct 9, 2026
- Date received
- Jan 12, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LJS
- Device type
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class II
- Regulation
- 21 CFR 880.5970
- Advisory committee
- General Hospital
- Statement or summary
- Summary
- Third party
- N
- Location
- Harleysville, PA, US