510(k) K990711
- Device
- CODAN CHEMOSPIKE
- Applicant
- CODAN US CORP.
- 510(k) number
- K990711
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-13
- Date received
- 1999-03-04
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FERGIE FERGUSON
- Address
- 3511 W. Sunflower Ave. Santa Ana CA US 92704 92704
FDA Registration Numbers#
- 1724474
- 3010432890
- 1424263
- 3030446844
- 3010160527
- 3012302888
- 3012307300
- 9615050
- 3027645738
- 3007014520
- 1530671
- 3010897183
- 3044026004
- 3000279201
- 3013445787
- 3011802635
- 3045751639
- 1056553
- 9615908
- 2011171
- 3008717264
- 3002808227
- 3043226252
- 3013481097
- 1420088
- 9617604
- 1058584
- 3020706315
- 3009265194
- 9614279
- 3009756327
- 3003704957
- 1713468
- 1319660
- 3005245797
- 3004201393
- 3009631669
- 3014579161
- 2032098
- 3014936217
- 1000632857
- 3015972753
- 9611665
- 3016938816
- 3020417125
- 9610825
- 1319639
- 2024024
- 1416980
- 3017406698
- 3008824097
- 1018470
- 3007880912
- 1526534
- 3038356900
- 3007221462
- 3013561817
- 1048735
- 3002807257
- 3008729892
- 9617594
- 2030624
- 3012429465
- 1928237
- 3005053560
- 3033527281
- 3003965134
- 8020347
- 2245270
- 1720929
- 3018125942
- 3011554160
- 9681819
- 1037885
- 3030447506
- 3009340644
- 1061927
- 1450662
- 3013234390
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 |
| 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 |
Legacy Summary#
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FDA Review#
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