510(k) K943038
- Device
- STATLOCK-IPIDURAL
- Applicant
- VENETEC, INC.
- 510(k) number
- K943038
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-10
- Date received
- 1994-06-27
- 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
- PATRICIA AMTOWER
- Address
- 1500 Quail St. Suite 550 Newport Beach CA US 92660 92660
FDA Registration Numbers#
- 3014162214
- 1530671
- 1723241
- 1820334
- 3015142721
- 3010872792
- 3007007790
- 3013557562
- 3032916632
- 3015085713
- 3006082230
- 3007392007
- 8021079
- 3006158088
- 3012050423
- 3008588205
- 3014662855
- 3003442380
- 3014936217
- 3011270181
- 3017567825
- 3013696225
- 1423507
- 2011171
- 1423662
- 3005458990
- 3004140833
- 3013055489
- 1932668
- 3007363456
- 1319660
- 1450392
- 3002806818
- 1928237
- 2183650
- 9615050
- 1055927
- 8021083
- 3010149039
- 3008650117
- 1217831
- 9615817
- 3002808467
- 3005515211
- 1417485
- 3002807090
- 3009976527
- 3010830834
- 3004102031
- 3022964615
- 3012116434
- 3013298431
- 2528981
- 9617475
- 1030451
- 1720734
- 3004194523
- 3004215921
- 3008537309
- 3016661372
- 1416980
- 9616099
- 3004416208
- 2011068
- 3014246639
- 3013319212
- 3035642068
- 1063851
- 3010515547
- 9611446
- 3005232773
- 9681835
- 3015983454
- 3018125942
- 3034669683
- 3014383500
- 1018233
- 3015058854
- 3042871620
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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