510(k) K950304
- Device
- DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
- Applicant
- BECTON DICKINSON VASCULAR ACCESS, INC.
- 510(k) number
- K950304
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-14
- Date received
- 1995-01-25
- 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
- C. J WELLE
- Address
- 9450 S. State St. Sandy UT US 84070 84070
FDA Registration Numbers#
- 1220973
- 3012552122
- 3047799708
- 3006082230
- 3005340341
- 2016945
- 3016798778
- 3010882065
- 3014383500
- 2649614
- 9617604
- 1911916
- 3014498869
- 1625425
- 1643817
- 3009742443
- 3002807090
- 3010273872
- 9680794
- 1038185
- 3009631669
- 3010413216
- 3020460367
- 3005609751
- 3006846316
- 3010293992
- 8010026
- 3027327302
- 9612152
- 2520313
- 1643059
- 3012798826
- 3012809732
- 3008692839
- 3004215921
- 1047843
- 3000268902
- 3011270181
- 9616567
- 9610993
- 1320894
- 3004140833
- 3006194679
- 3015309643
- 1450392
- 3012969104
- 3008650117
- 3033589330
- 3012421607
- 9616662
- 1423537
- 9615817
- 3003895440
- 2243072
- 1724474
- 3020777588
- 1833470
- 3005951712
- 3013517171
- 3015453963
- 3004911384
- 3004735647
- 3006174295
- 1419937
- 3008733163
- 3010621964
- 3011088743
- 1649518
- 1000304305
- 1928237
- 3018071447
- 1016427
- 2025816
- 3017406698
- 1416980
- 9681819
- 3016096098
- 3030419987
- 8021545
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#
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