510(k) K964989
- Device
- CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5)
- Applicant
- CRITICAL DEVICE CORP.
- 510(k) number
- K964989
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-02
- Date received
- 1996-12-13
- 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
- DAN HYUN
- Address
- 499 Nibus St. Brea CA US 92621 92621
FDA Registration Numbers#
- 3007221462
- 3016938816
- 3007829657
- 3008810357
- 1223004
- 3030626857
- 3030446844
- 3004194523
- 2650143
- 3007649127
- 3003768277
- 1450662
- 2016945
- 2030624
- 1420088
- 3014579161
- 9612052
- 3003974574
- 1061927
- 3042177665
- 3007880912
- 3015276780
- 3002682307
- 2022435
- 3017636737
- 2649614
- 3013764800
- 2953359
- 3003152976
- 3018125942
- 9617604
- 3013557562
- 1643817
- 3043226252
- 1423507
- 3012410077
- 1035907
- 3018503755
- 2950467
- 3003965134
- 3020417125
- 3009631669
- 3010512490
- 2030598
- 3015531959
- 9614279
- 3044026004
- 3013319212
- 3000279201
- 3007014520
- 9610825
- 9616066
- 3014312726
- 9611665
- 3001124136
- 3009265194
- 3009756327
- 3010659131
- 9617594
- 3020706315
- 1056553
- 3005941719
- 3003678543
- 3013234390
- 3010329663
- 1000632857
- 2521402
- 3023851856
- 1720929
- 1424263
- 1048735
- 8020347
- 2520313
- 1037885
- 3012429465
- 3012798826
- 3016418550
- 3010432890
- 3005245797
- 1019003
Source Documents#
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#
summary
FDA Review#
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