510(k) K173399
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2017
- Date Received
- October 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type