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FDA 510(k)

IV Sets not made with PVC

K-Number: K191658 · 2020-03-19

ApplicantB.Braun Medical, Inc.
Decision Date2020-03-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV Sets not made with PVC is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-03-19 under 510(k) number K191658. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IV Sets not made with PVC?

IV Sets not made with PVC is a medical device that received FDA 510(k) clearance on 2020-03-19. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K191658.

When did IV Sets not made with PVC receive FDA 510(k) clearance?

IV Sets not made with PVC received FDA 510(k) clearance on 2020-03-19, under 510(k) number K191658.

Who is the listed applicant for IV Sets not made with PVC?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IV Sets not made with PVC?

The FDA product code for IV Sets not made with PVC is FPA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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