510(k) K153238
K153238 is an FDA 510(k) premarket notification submitted by Medcomp ( Medical Components) for the device "Dignity Dual Port". The FDA issued a decision of Substantially Equivalent on March 15, 2016. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medcomp ( Medical Components) has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 15, 2016
- Date Received
- November 9, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5965
- Review Panel
- HO
- Submission Type