510(k) K111217
K111217 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ADDITIVE CAP". The FDA issued a decision of Substantially Equivalent on June 14, 2011. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2011
- Date Received
- May 2, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type