510(k) K993463
- Device
- INTRAVASCULAR ADMINISTRATION SET
- Applicant
- CUSTOM ASSEMBLIES, INC.
- 510(k) number
- K993463
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-04
- Date received
- 1999-10-13
- 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
- PAUL E DRYDEN
- Address
- 6329 W. Waterview Ct. Mccordsville IN US 46055 46055
FDA Registration Numbers#
- 3010934635
- 3008806809
- 1055927
- 3000247873
- 3012410077
- 3002296055
- 3013764800
- 3015620563
- 3017210488
- 1720929
- 3020417125
- 3003442380
- 3000240707
- 3006575795
- 3027327302
- 3013188547
- 1062381
- 3018125942
- 3006534321
- 2032521
- 3015142721
- 9680222
- 3010621964
- 3010830834
- 1018233
- 1060680
- 3035642068
- 3020777588
- 1019003
- 9680787
- 8041187
- 9610847
- 1723241
- 3005778453
- 1647137
- 1417485
- 3014312726
- 3016661372
- 3004538333
- 9610993
- 3012116434
- 2427500
- 3003895440
- 3004111573
- 3012798826
- 3008650117
- 3017088037
- 3008307705
- 2523676
- 3005012805
- 3014456066
- 3033589330
- 3016727301
- 3017406698
- 3015997711
- 3004569180
- 2648727
- 3006891665
- 1000304305
- 3004167615
- 3009746425
- 2024024
- 9615588
- 3014498869
- 3005232773
- 3011237770
- 3002907620
- 1043214
- 3004194523
- 1316297
- 3005405146
- 3015537049
- 1530671
- 3010149039
- 1314417
- 3030989877
- 9615817
- 1056186
- 3017509841
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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