510(k) K003535
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2001
- Date Received
- November 16, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1380
- Review Panel
- CV
- Submission Type