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FDA 510(k)

Medline Cardiovascular Procedure Kit

K-Number: K212258 · 2021-12-03

Decision Date2021-12-03
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Cardiovascular Procedure Kit is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-12-03 under approval number K212258. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline Cardiovascular Procedure Kit?

Medline Cardiovascular Procedure Kit is a medical device that received FDA 510(k) clearance on 2021-12-03. It is manufactured by Medline Industries, Inc.. The 510(k) number is K212258.

When was Medline Cardiovascular Procedure Kit approved by the FDA?

Medline Cardiovascular Procedure Kit received FDA 510(k) clearance on 2021-12-03, under approval number K212258.

What company makes Medline Cardiovascular Procedure Kit?

Medline Cardiovascular Procedure Kit is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline Cardiovascular Procedure Kit?

The FDA product code for Medline Cardiovascular Procedure Kit is LRO.

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Official Source

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