510(k) K964853
K964853 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "INTRAVIA CONTAINER, EMPTY". The FDA issued a decision of Substantially Equivalent on Mar 31, 1997. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 1997
- Date Received
- Dec 3, 1996
- 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
- 510(k)