510(k) K103224
K103224 is an FDA 510(k) premarket notification submitted by Hospira, Inc. for the device "HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING". The FDA issued a decision of Substantially Equivalent on January 7, 2011. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Hospira, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2011
- Date Received
- November 1, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type