FDA.report

510(k) K931377

Device
SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT
Applicant
Mcgaw, Inc.
510(k) number
K931377
Product code
FPA
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-07
Date received
1993-03-18
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN G D'ANGELO
Address
2525 Mcgaw Ave. P.O. Box 19791 Irvine CA US 92713 92713

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code FPA

510(k)DeviceApplicantDecision date
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K242692SteadiSet Infusion SetCapillary Biomedical, LLC2025-05-09
K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.2025-05-02
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K242339Intravascular Extension Sets and AccessoriesBaxter Healthcare Corporation2025-02-28
K241058Lyka® PORT Needle Free Access Device (4170Y)Quest Medical, Inc.2024-12-18
K234129Ecomed Disposable Administration SetsEcomed Solutions, LLC2024-09-20