510(k) K192807
K192807 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. (dba MedComp) for the device "Duo-Flow Side x Side Double Lumen Catheter". The FDA issued a decision of Substantially Equivalent on April 23, 2020. The device falls under product code MPB (Catheter, Hemodialysis, Non-Implanted), a Class II device regulated under 21 CFR 876.5540. Medical Components, Inc. (dba MedComp) has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2020
- Date Received
- October 1, 2019
- 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