510(k) K180128
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2018
- Date Received
- January 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type