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FDA 510(k)

Mini Spike Plus 6/8R

K-Number: K201469 · 2020-12-09

ApplicantB.Braun Medical, Inc.
Decision Date2020-12-09
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Mini Spike Plus 6/8R 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 2020-12-09 under 510(k) number K201469. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mini Spike Plus 6/8R?

Mini Spike Plus 6/8R is a medical device that received FDA 510(k) clearance on 2020-12-09. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K201469.

When did Mini Spike Plus 6/8R receive FDA 510(k) clearance?

Mini Spike Plus 6/8R received FDA 510(k) clearance on 2020-12-09, under 510(k) number K201469.

Who is the listed applicant for Mini Spike Plus 6/8R?

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 Mini Spike Plus 6/8R?

The FDA product code for Mini Spike Plus 6/8R is LHI.

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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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