510(k) K945617
- Device
- PHARMA-PLAST PURELINE(TM) BASIC(TM) AND PURELINE(TM) CONTACT(TM) SUBCUTANEOUS INFUSION SETS
- Applicant
- PHARMA-PLAST INTL. A/S
- 510(k) number
- K945617
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-02-13
- Date received
- 1994-11-15
- 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
Related Records
Applicant Contact
- Contact
- ANDERS KOLDING
- Address
- Engmosen-1 Lynge DK DK-3540 DK-3540
FDA Registration Numbers
- 3017262697
- 3002806818
- 1423537
- 1221765
- 1063851
- 1024879
- 3011987967
- 3003674698
- 1526611
- 8041145
- 3034669683
- 2024064
- 3013696225
- 3011642792
- 8040700
- 9616099
- 3005778453
- 9680306
- 3003974574
- 3015997711
- 1047843
- 2032521
- 2433012
- 3005458990
- 1054241
- 1928237
- 9612057
- 3007616112
- 1410248
- 9681835
- 9611665
- 9610847
- 3017567825
- 9610825
- 3010149039
- 1220477
- 9615050
- 1019003
- 3010273872
- 3018229072
- 3022964615
- 1016427
- 9612051
- 3022699058
- 2243072
- 3007344957
- 3016472589
- 3007363456
- 1820334
- 1422078
- 1417485
- 3004911384
- 1061124
- 3012187635
- 3010293992
- 1526863
- 3012410077
- 3017509841
- 3008448733
- 3030733800
- 9610993
- 3016904853
- 2320762
- 3008782867
- 3015140199
- 3012104670
- 1424263
- 3019807891
- 3010381606
- 3020417125
- 3015724078
- 3017961114
- 3005934752
- 2032098
- 3012429465
- 3012969104
- 9681572
- 1038185
- 3005669815
Source Documents
Other 510(k) Records For Product Code FPA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 |
Legacy Summary
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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