510(k) K170934
K170934 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 Dec 6, 2017. 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.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 2017
- Date Received
- Mar 30, 2017
- Clearance Type
- Traditional
- 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
- 510(k)