510(k) K895030
K895030 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "LIFE-LINE(TM) VASCULAR ACCESS SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on April 17, 1990. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 17, 1990
- Date Received
- August 8, 1989
- 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