510(k) K202176
K202176 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. (dba MedComp) for the device "Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes". The FDA issued a decision of Substantially Equivalent on September 3, 2020. The device falls under product code MSD (Catheter, Hemodialysis, 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
- September 3, 2020
- Date Received
- August 4, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Hemodialysis, Implanted
- Device Class
- Class II
- Regulation Number
- 876.5540
- Review Panel
- GU
- Submission Type