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
FDA 510(k) clearance K201142 · decided 2021-02-25
Clearance details
- K-number
- K201142
- Device name
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-29
- Decision date
- 2021-02-25
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- ONB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Kiryat Shmona, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.