510(k) K201142
- Device
- TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL With ULTRASITE, TEVADAPTOR Bag Adaptor SP With ULTRASITE, TEVADAPTOR IV Secondary Safety Set With ULTRASITE, TEVADAPTOR IV Secondary Safety Set
- Applicant
- Simplivia Healthcare Ltd.
- 510(k) number
- K201142
- Product code
- ONB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-25
- Date received
- 2020-04-29
- Regulation
- 880.5440
- Classification name
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
- 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
- Shay Shaham
- Address
- North Industrial Zone Kiryat Shmona IL 1011801 1011801
FDA Registration Numbers#
- 3013055489
- 3008717264
- 3018681450
- 9616066
- 3030384100
- 3030733800
- 3008349578
- 3008468447
- 3012429465
- 3002806603
- 3003152976
- 3010423292
- 3002682307
- 9611423
- 3012494290
- 2243072
- 3030626857
- 3009631669
- 3009340644
- 3013764800
- 3013319212
- 2032112
- 3043226252
- 3013557562
- 3002808227
- 3008434487
- 3015462350
- 3007829657
- 9617594
- 3010882708
- 3012410077
- 1713468
- 1423507
- 2024024
- 3008729892
- 2025816
- 1710034
- 2032098
- 3012039263
- 3012798826
Source Documents#
Other 510(k) Records For Product Code ONB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251722 | ProSeal™ Transfer Injector (421120, 421130, 421140) | Epic Medical Pte. , Ltd. | 2025-12-05 |
| K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare , Ltd. | 2025-10-21 |
| K250059 | BD PhaSeal™ Optima Connecting Set (C83-O); BD PhaSeal™ Optima Spike Set (C180-O) | Becton, Dickinson and Company | 2025-09-12 |
| K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare , Ltd. | 2025-08-05 |
| K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte. , Ltd. | 2025-05-29 |
| K243976 | ZeroClear™ Bag Access (423100) | Epic Medical Pte. , Ltd. | 2025-01-22 |
| K240517 | ProSeal™ Vented Universal Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-12-26 |
| K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte. , Ltd. | 2024-10-23 |
| K241735 | ProSeal™ In Line Pump Set (423850) | Epic Medical Pte. , Ltd. | 2024-10-10 |
| K241823 | ToxiSeal™ Vial Adaptor | Epic Medical Pte. , Ltd. | 2024-08-30 |
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte. , Ltd. | 2024-06-21 |
| K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | Epic Medical Pte. , Ltd. | 2024-05-21 |
| K240171 | ProSeal™ Injector Plus (Model no. 421050) | Epic Medical Pte. , Ltd. | 2024-03-28 |
| K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte. , Ltd. | 2024-01-11 |
| K231286 | Chemfort® Catheter Adaptor | Simplivia Healthcare , Ltd. | 2023-08-02 |
Legacy Summary#
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FDA Review#
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