FDA.report

510(k) K072576

Device
CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K072576
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
2007-11-06
Date received
2007-09-13
Regulation
880.5440
Classification name
Set, Administration, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
NANETTE HEDDEN
Address
1620 Waukegan Rd., Mpgr-Al Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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