510(k) K130897
K130897 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "MEDCOMP VASCU-PICC WITH VALVE". The FDA issued a decision of Substantially Equivalent on October 22, 2013. 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. Medcomp ( Medical Components) has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2013
- Date Received
- April 1, 2013
- 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