510(k) K980381
- Device
- PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
- Applicant
- CARMEL PHARMA AB.
- 510(k) number
- K980381
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-03-03
- Date received
- 1998-02-02
- Regulation
- 880.5440
- Classification name
- Set, I.v. Fluid Transfer
- 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
- BRITT NOVEN
- Address
- Box 5352 Gothenburg SE 40228 40228
FDA Registration Numbers#
- 2245590
- 3003965134
- 9610825
- 1061124
- 1000150646
- 3013188547
- 1000632857
- 1526534
- 9613744
- 3003974574
- 3011554160
- 2022435
- 3030447506
- 1424263
- 1720929
- 3003678543
- 3030626857
- 3009631669
- 3000279201
- 2950467
- 3015085713
- 9710018
- 3002808227
- 1217831
- 3008824097
- 3022555290
- 3006571738
- 3001124136
- 3012410077
- 3013561817
- 3007014520
- 1056553
- 3014579161
- 3007681502
- 2025816
- 2011171
- 3013298431
- 3016566166
- 3010160527
- 3014342658
- 9611157
- 3012798826
- 1416980
- 1055927
- 3044026004
- 1417592
- 1000163068
- 2245304
- 3030201489
- 9681819
- 3004548776
- 2521402
- 3015276780
- 3010329663
- 3042177665
- 3000223297
- 1423662
- 3002807257
- 3013319212
- 2032112
- 3015972753
- 3043226252
- 1724474
- 8031007
- 2245270
- 3007221462
- 3004194523
- 3013557562
- 3010432890
- 3033527281
- 1450662
- 9617594
- 1928237
- 3007649127
- 3002907620
- 3006979803
- 3017406698
- 3010659131
- 3013820501
Source Documents#
Other 510(k) Records For Product Code LHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | 2025-09-16 |
| K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | 2024-03-06 |
Legacy Summary#
summary
FDA Review#
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