Tandem Sets I.V.

FDA 510(k) K850757 · Acacia, Inc.

Substantially Equivalent

510(k) numberK850757

Submission

Device name
Tandem Sets I.V.
Applicant
Acacia, Inc.
Loma Linda, CA, US
Received
February 25, 1985
Decision date
April 4, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LHI – Set, I.V. Fluid Transfer
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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Questions and answers

When was Tandem Sets I.V. cleared by the FDA?

Tandem Sets I.V. (K850757) received a 510(k) decision of Substantially Equivalent on April 4, 1985, 38 days after the submission was received.

What is the product code of K850757?

The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.