510(k) K072576

CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED by Baxter Healthcare Corp — Product Code FPA

K072576 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED". The FDA issued a decision of Substantially Equivalent on Nov 6, 2007. 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 6, 2007
Date Received
Sep 13, 2007
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 K072576. Report a data issue: hello@regdatalab.com.