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510(k) K040636

Device
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET
Applicant
SMITHS MEDICAL MD, INC.
510(k) number
K040636
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
2004-05-19
Date received
2004-03-10
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

Applicant Contact#

Contact
PATRICIA A LAFORTE
Address
1265 Grey Fox Rd. St. Paul MN US 55112 55112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FPA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.2026-05-04
K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.2026-02-12
K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np Medical2025-12-04
K250325BD Alaris Pump Infusion SetCarefusion (Bd)2025-10-30
K251814EZ™ IV Administration SetEpic Medical Pte. , Ltd.2025-08-29
K251854SteadiSet infusion setTandem Diabetes Care2025-08-06
K243841Sparta Infusion Set for InsulinDeka Research and Development2025-08-01
K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc.2025-07-24
K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc.2025-06-05
K242692SteadiSet Infusion SetCapillary Biomedical, LLC2025-05-09
K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.2025-05-02
K243529Solution Administration SetsBaxter Healthcare Corporation2025-03-14
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

Legacy Summary#

summary

FDA Review#

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