510(k) K153487
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS by
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
— Product Code LJS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2016
- Date Received
- December 4, 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