510(k) K841468
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1984
- Date Received
- April 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instruments, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type