510(k) K052432
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2005
- Date Received
- September 6, 2005
- 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