510(k) K911315
K911315 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT". The FDA issued a decision of Substantially Equivalent on Oct 30, 1991. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 1991
- Date Received
- Mar 26, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Accessories, Blood Circuit, Hemodialysis
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)