510(k) K183066
The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD Technology-3 Fr, 4 Fr, and 5 Fr Model by
Access Scientific, LLC
— Product Code DYB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2019
- Date Received
- November 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type