510(k) K926496
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1995
- Date Received
- December 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Irrigation
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type