510(k) K910339
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 29, 1991
- Date Received
- January 28, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Occluder, Catheter Tip
- Device Class
- Class II
- Regulation Number
- 870.1370
- Review Panel
- CV
- Submission Type