510(k) K912211
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 9, 1991
- Date Received
- May 20, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Intravascular Catheter Securement
- Device Class
- Class I
- Regulation Number
- 880.5210
- Review Panel
- HO
- Submission Type