I.V. Administration Set

FDA 510(k) K210381 · Bq Plus Medical Co., Ltd.

Substantially Equivalent

510(k) numberK210381

Submission

Device name
I.V. Administration Set
Applicant
Bq Plus Medical Co., Ltd.
Shanghai, CN
Received
February 9, 2021
Decision date
August 14, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPA – Set, Administration, Intravascular
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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More from B.Braun Medical, Inc.

510(k)DeviceDecision
K242126I.V. Administration SetFPA · Special 08/22/2024SE
K223645I.V. Administration Set, I.V. Extension SetFPA · Traditional 05/18/2023SE

Questions and answers

When was I.V. Administration Set cleared by the FDA?

I.V. Administration Set (K210381) received a 510(k) decision of Substantially Equivalent on August 14, 2021, 186 days after the submission was received.

What is the product code of K210381?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.