510(k) K140133
- Device
- INFUSET FLOW CONTROL EXTENSION SET
- Applicant
- EMED TECHNOLOGIES CORPORATION
- 510(k) number
- K140133
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-15
- Date received
- 2014-01-17
- 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
- PETER KOLLINGS
- Address
- 1264 Hawks Flight Ct., Suite 200 El Dorado Hills CA US 95762 95762
FDA Registration Numbers#
- 3004569180
- 3013696225
- 3002808466
- 9612052
- 3015192982
- 9614279
- 3023228837
- 1319639
- 3020460367
- 3031233007
- 3011088743
- 3007392007
- 3010381606
- 1019003
- 8020785
- 1423537
- 3008537309
- 3030419987
- 3000268902
- 3036773433
- 3004906872
- 2024064
- 3013055489
- 2016945
- 9680794
- 3015142721
- 3008588205
- 3019004087
- 1217831
- 1314417
- 3007344957
- 9680448
- 3017961114
- 3003974574
- 3009742443
- 3013820501
- 1061124
- 3030626857
- 3006950086
- 3015859709
- 3017406698
- 9616088
- 3004111573
- 3012552122
- 1720734
- 3017088037
- 1000587249
- 1220973
- 2649614
- 3002808467
- 3010413216
- 3005515211
- 3012410077
- 3012039263
- 3009328501
- 3035642068
- 1530671
- 9610847
- 3005669815
- 1000563940
- 3012050423
- 3012536737
- 3002296055
- 1720929
- 3038356900
- 3014662855
- 9616066
- 3045322464
- 1000324175
- 3003627840
- 3010934635
- 3012494290
- 9617604
- 3034669683
- 1526863
- 2030624
- 3013557562
- 1047843
- 3015537049
Source Documents#
Other 510(k) Records For Product Code FPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026-09-11 |
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 |
| K252543 | AMSafe 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 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 |
| K251814 | EZ™ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 |
| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 |
Legacy Summary#
summary
FDA Review#
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