510(k) K942046
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1994
- Date Received
- April 28, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type