FDA.reportPublic FDA data

510(k) K780130

Device
BURETTE INTRAVENOUS ADMIN. SETS.
Applicant
Y
510(k) number
K780130
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-02-21
Date received
1978-01-24
Regulation
880.5440
Classification name
Set, Administration, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FPA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC2026-09-11
K261530iiSure Infusion SetDeka Research and Development2026-06-03
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases