510(k) K810531
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1981
- Date Received
- February 26, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Catheter
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type