510(k) K980992
- Device
- IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
- Applicant
- VENETEC INTL., INC.
- 510(k) number
- K980992
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-28
- Date received
- 1998-03-17
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GRACE HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
FDA Registration Numbers#
- 3005458990
- 3006479639
- 3010515547
- 3034669683
- 3027327302
- 3006795797
- 3017961114
- 9680306
- 3005382983
- 1047843
- 1724474
- 3010432890
- 3016727301
- 9681835
- 2520313
- 9611446
- 9615908
- 3007738736
- 3005232773
- 1932668
- 3009515470
- 2649614
- 1833470
- 3011944170
- 3008328679
- 3020460367
- 3010291427
- 3008252904
- 2030598
- 3011137372
- 1055236
- 1647137
- 1450392
- 3015453963
- 2321034
- 2427500
- 3007817041
- 3017567825
- 1319660
- 3030447506
- 3002296055
- 3015276780
- 3003974574
- 8021083
- 3004569180
- 3007939342
- 3009518015
- 2024064
- 9615817
- 9616848
- 1220973
- 9680787
- 1644312
- 3019004087
- 2032098
- 3003442380
- 9680448
- 9616088
- 1018233
- 1054241
- 3004099493
- 3005987567
- 3006950086
- 1319639
- 1000523114
- 2011171
- 3015309643
- 1410248
- 3007590959
- 1063382
- 3014383500
- 9617594
- 2032112
- 8021079
- 3003927385
- 3044026004
- 3030733800
- 9612051
- 3020417125
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FPA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 |
Legacy Summary#
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FDA Review#
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