510(k) K242126

I.V. Administration Set by Bq Plus Medical Co., Ltd. — Product Code FPA

K242126 is an FDA 510(k) premarket notification submitted by Bq Plus Medical Co., Ltd. for the device "I.V. Administration Set". The FDA issued a decision of Substantially Equivalent on August 22, 2024. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Bq Plus Medical Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2024
Date Received
July 19, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type