510(k) K153423
CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC by
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
— Product Code LJS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 2016
- Date Received
- November 25, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type