510(k) K042936

SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE by Baxter Healthcare Corp — Product Code FPA

K042936 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE". The FDA issued a decision of Substantially Equivalent on Nov 26, 2004. 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
Nov 26, 2004
Date Received
Oct 25, 2004
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 K042936. Report a data issue: hello@regdatalab.com.