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FDA PMA

Lipoprotein, low density, removal

PMA Number: P910018 · 2026-06-16

ApplicantKaneka Pharma America Corp.
Decision Date2026-06-16
PMA NumberP910018
Product CodeMMY
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Lipoprotein, low density, removal is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Pharma America Corp.. It received FDA 510(k) clearance on 2026-06-16. The device is classified under product code MMY. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Lipoprotein, low density, removal?

Lipoprotein, low density, removal is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Kaneka Pharma America Corp..

When did Lipoprotein, low density, removal receive FDA 510(k) clearance?

The clearance date for Lipoprotein, low density, removal can be found in the official FDA records.

Who is the listed applicant for Lipoprotein, low density, removal?

The FDA 510(k) record lists Kaneka Pharma America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lipoprotein, low density, removal?

The FDA product code for Lipoprotein, low density, removal is MMY.

Related Clinical Trials

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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