510(k) K171618
K171618 is an FDA 510(k) premarket notification submitted by Medcomp (Dba Medical Components, Inc.) for the device "Symetrex Long Term Hemodialysis Catheter". The FDA issued a decision of Substantially Equivalent (kit) on November 16, 2017. The device falls under product code MSD (Catheter, Hemodialysis, Implanted), a Class II device regulated under 21 CFR 876.5540. Medcomp (Dba Medical Components, Inc.) has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 16, 2017
- Date Received
- June 2, 2017
- Clearance Type
- Traditional
- 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