510(k) K021142
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2002
- Date Received
- April 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention Type, Balloon
- Device Class
- Class II
- Regulation Number
- 876.5130
- Review Panel
- GU
- Submission Type