510(k) clearances

PIVO™ Pro Needle-free Blood Collection Device

Becton Dickinson Infusion Therapy Systems, Inc. · Clinical Chemistry

K241586Substantially EquivalentTraditionalJKA
Open FDA's page for this record
Third party flag
N
City
Sandy
Advisory committee description
Clinical Chemistry
Address 1
9450 S. State St.
Statement or summary
Summary
Product code
JKA
Zip code
84070
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
Decision date
2025-02-27
Decision code
SESE
Country code
US
Device name
PIVO™ Pro Needle-free Blood Collection Device
Advisory committee
CH
Contact
Amy Moore
K number
K241586
State
UT
Date received
2024-06-03
Review advisory committee
HO
Postal code
84070
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Medical specialty description
Clinical Chemistry
Regulation number
862.1675
Device class
2
Registration number
3008496607, 3030243919, 1055927, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 3015058854, 3019807891, 1058602, 3026940910, 3030626857, 3037918935, 1917413, 3008337059, 1055236, 3024537844, 3009518015, 3006425876, 9616567, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 9681835, 3013652330, 3044026004, 3001124136, 3019004087, 9680794, 8010026, 3014662855, 3035708936 +180 more
FEI number
3008496607, 3030243919, 2648045, 3017509841, 3030446844, 3000268902, 3020294761, 3013298431, 2828, 1000113359, 3003282181, 3015058854, 3019807891, 3000974732, 3026940910, 3030626857, 3037918935, 1000208624, 1917413, 3008337059, 3024537844, 3009518015, 3006425876, 3005674478, 3013696225, 3009742443, 3016661372, 3042871620, 3043226252, 3003974574, 3033589330, 3005910889, 3000206435, 3013652330, 3044026004, 3002808075, 3001236905, 2649711, 3001124136, 3019004087 +180 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.