Atlas FDA

BD FlowSmart Set/MiniMed Pro-Set

FDA 510(k) clearance K181718 · decided 2018-10-18

Clearance details

K-number
K181718
Device name
BD FlowSmart Set/MiniMed Pro-Set
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2018-06-29
Decision date
2018-10-18
Days to decision
111 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Franklin Lakes, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15