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FDA 510(k)

Medline Cardiovascular Procedure Kit

K-Number: K212258 · 2021-12-03

ApplicantMedline Industries, Inc.
Decision Date2021-12-03
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline Cardiovascular Procedure Kit is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) 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. The listed applicant is Medline Industries, Inc.. The 510(k) number is K212258.

When did Medline Cardiovascular Procedure Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline Cardiovascular Procedure Kit?

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

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

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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