510(k) K191664
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 2019
- Date Received
- June 21, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type