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FDA 510(k)

IV Administration Sets

K-Number: K202618 · 2021-09-24

ApplicantB.Braun Medical, Inc.
Decision Date2021-09-24
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IV Administration Sets 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 2021-09-24 under 510(k) number K202618. 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 Administration Sets?

IV Administration Sets is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K202618.

When did IV Administration Sets receive FDA 510(k) clearance?

IV Administration Sets received FDA 510(k) clearance on 2021-09-24, under 510(k) number K202618.

Who is the listed applicant for IV Administration Sets?

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 Administration Sets?

The FDA product code for IV Administration Sets is FPA.

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Related Devices (Code: FPA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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