510(k) K920694

8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET by Baxter Healthcare Corp — Product Code FPA

K920694 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET". The FDA issued a decision of Substantially Equivalent on Mar 23, 1992. The device falls under product code FPA (Set, Administration, Intravascular), 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
Mar 23, 1992
Date Received
Feb 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type
510(k)

Source: FDA 510(k) database entry for K920694. Report a data issue: hello@regdatalab.com.