510(k) K954906
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1996
- Date Received
- October 25, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type