510(k) K881690
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1988
- Date Received
- April 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Port & Catheter, Implanted, Subcutaneous, Intraventricular
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- HO
- Submission Type