510(k) K113470
- Device
- NIPRO SAFE TOUCH HUBER INFUSION SET
- Applicant
- NIPRO MEDICAL CORPORATION
- 510(k) number
- K113470
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-17
- Date received
- 2011-11-22
- 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
- JESSICA OSWALD
- Address
- 3150 NW 107th Ave. Miami FL US 33172 33172
FDA Registration Numbers#
- 3010405396
- 1024879
- 1424263
- 3003442380
- 2321034
- 1649914
- 3004143450
- 9617592
- 9615050
- 1723241
- 1530671
- 3004111573
- 3020778
- 3008692839
- 3008717264
- 3010082909
- 3004099493
- 9680425
- 1647137
- 3017088037
- 3011689956
- 3002296055
- 3004735647
- 3006158088
- 8022210
- 3003704957
- 1319660
- 3017210488
- 3014579161
- 3009976527
- 1063382
- 3010041511
- 1221765
- 1911916
- 3010381606
- 1056186
- 1319639
- 3000240707
- 3005669815
- 3022964615
- 3017961114
- 9611590
- 9611423
- 3008448733
- 3004140833
- 2032227
- 2030624
- 1055236
- 3012429465
- 1928237
- 3029706818
- 3005382983
- 1720929
- 1037885
- 3013696225
- 1000595987
- 3010966701
- 3032916632
- 1417485
- 3009518015
- 3005951712
- 3003678543
- 9681413
- 3006795797
- 1000112137
- 3034669683
- 1423537
- 3009515470
- 3016661372
- 3011944170
- 1223925
- 1820334
- 3008537309
- 3030419987
- 3015225571
- 3012969104
- 3002806603
- 1410248
- 3005941719
Source Documents#
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#
summary
FDA Review#
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