510(k) K931441
K931441 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "FENWAL 40 MICRON TRANSFUSION FILTER". The FDA issued a decision of Substantially Equivalent on Sep 21, 1993. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 21, 1993
- Date Received
- Mar 22, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filter, Infusion Line
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type
- 510(k)