510(k) K901063
- Device
- LUER LOCK TRANSFER PIN
- Applicant
- ACACIA, INC.
- 510(k) number
- K901063
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-07-06
- Date received
- 1990-03-07
- Regulation
- 880.5440
- Classification name
- Set, I.v. Fluid Transfer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARGARET LUMIA,PHARM
- Address
- P.O. Box 1240 Loma Linda CA US 92354 92354
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#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHI #
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|---|---|---|---|
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| 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 |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | 2024-03-06 |