FDA.report

510(k) K081289

Device
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE
Applicant
BAXTER HEALTHCARE CORP.
510(k) number
K081289
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
2008-08-04
Date received
2008-05-07
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. Mcgaw Park IL US 60085 60085

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
50085412088346V-LINK/VITALSHIELDBAXTER INTERNATIONAL INC.2016-09-24
50085412088322V-LINK/VITALSHIELDBAXTER INTERNATIONAL INC.2016-09-24
50085412088308V-LINK/VITALSHIELDBAXTER INTERNATIONAL INC.2016-09-24

Legacy Summary

summary

FDA Review

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