510(k) K113277
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS by
Arrow International, Inc.
— Product Code LJS
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2012
- Date Received
- November 7, 2011
- Clearance Type
- Traditional
- 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