Cleared Traditional

Safety Sliding Blood Collection Set

K232781 · Jiangsu Caina Medical Co.,Ltd · General Hospital
Mar 2024
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K232781 is an FDA 510(k) clearance for the Safety Sliding Blood Collection Set, a Tubes, Vials, Systems, Serum Separators, Blood Collection (Class II — Special Controls, product code JKA), submitted by Jiangsu Caina Medical Co.,Ltd (Jiangyin, CN). The FDA issued a Cleared decision on March 7, 2024, 178 days after receiving the submission on September 11, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 862.1675.

Submission Details

510(k) Number K232781 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2023
Decision Date March 07, 2024
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1675

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