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510(k) K243207

BD Vacutainer® Eclipse™ Blood Collection Needle by Becton, Dickinson and Company — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
October 1, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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Other clearances for product code JKA

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  • K250907 — Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (April 30, 2025)
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  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
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