510(k) K233021

Device: BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
Applicant: Care Fusion
510(k) number: K233021
Product code: LHI
Decision: Substantially Equivalent (SESE)
Decision date: 2024-03-06
Date received: 2023-09-22
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: N

Related Records

Applicant Contact

Contact: Stefanee Smith
Address: 10020 Pacific Mesa Blvd. San Diego CA US 92121 92121

FDA Registration Numbers

1423662
1450662
2521402
3038356900
3013820501
1423507
8021083
1416980
2650143
1061124
3011392709
1720734
3020706315
3013234390
3015531959
3017406698
3016418550
9614854
3010291427
1037885
3042177665
3013188547
9615908
1000150646
1035907
3020417125
2032098
1018470
3012429465
1019003
2649614
3006946348
3030447506
3015176617
1420088
2016945
3001124136
3013557562
8031007
1319660
3007880912
3003704957
1000163068
3015488952
3012307300
3003678543
3013298431
3003152976
3017636737
2024024
9612052
3009340644
3004194523
3009756327
9681819
3003674698
3008810357
3005245797
3000279201
3018125942
3030626857
1835568
9614279
3002907620
3013319212
3004201393
3009631669
1058584
3004548776
2953359
1530671
3013561817
3027645738
1713468
3003768277
3013445787
3000223297
1526863
3014579161
3005042488
1417592
1928237
3010329663
1526534
1724474
3002807257
1319639
3003965134
9615050
9610825
2245270
1061927
3011802635
9611665
1056553
3007649127
3002808227
2245590
2245304
3005053560
9710643
3006571738
3010160527
3012798826
2030624
3006979803
3010432890
3030446844
1720929
2523676
3005941719
3012494290
3023851856
3010659131
1833470
3013764800
1000632857
3007221462
3022555290
2032112
3016761372
1223004
1217831
3014312726
1410248
3015972753
2030598
9616066
3004911384
1047843
3013481097
3016566166
1055927
1643817
3014342658
1314417
3002682307
3003974574
3011554160
9610847
2029275
3004986960
1048735
3016938816
3015085713
3030201489
8020347
9613744
1000324175
2025816
2520313
2950467
9611157
2244478
3007143236
3018503755
3006610642
3043226252
3033527281
9681240
3007829657
3015276780
3008824097
9617594
3009265194
3010512490
2011171
2022435
9617604
1424263
9710018
3007014520
3014936217
3010897183
3007681502
3008729892
3012410077

Source Documents

510(k) summary PDF

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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
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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
K231071	Mix2Vial® Transfer Device	West Pharma. Services IL, Ltd.	2024-01-19
K232875	Vial Adapter 20mm	West Pharma. Services IL, Ltd.	2023-12-14