510(k) K922896
K922896 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL". The FDA issued a decision of Substantially Equivalent (kit) on March 20, 1993. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Med Institute, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 20, 1993
- Date Received
- June 16, 1992
- 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