510(k) K200426
K200426 is an FDA 510(k) premarket notification submitted by Health Line International Corporation for the device "Acute Dual Lumen Hemodialysis Catheter". The FDA issued a decision of Substantially Equivalent (kit) on December 24, 2020. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Health Line International Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 24, 2020
- Date Received
- February 21, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Non-Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type