510(k) K180567
K180567 is an FDA 510(k) premarket notification submitted by Medical Components, Inc. (dba MedComp) for the device "C3 Wave System". The FDA issued a decision of Substantially Equivalent on April 12, 2018. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Medical Components, Inc. (dba MedComp) has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2018
- Date Received
- March 5, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type