510(k) K934803
K934803 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS". The FDA issued a decision of Substantially Equivalent on Dec 17, 1993. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), 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
- Dec 17, 1993
- Date Received
- Oct 20, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type
- 510(k)