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FDA PMA

Intravascular radiation delivery system

PMA Number: P000018 · 2024-09-26

ApplicantBest Vascular, Inc.
Decision Date2024-09-26
PMA NumberP000018
Product CodeMOU
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Intravascular radiation delivery system is the device name listed in this FDA 510(k) record. The listed applicant is Best Vascular, Inc.. It received FDA 510(k) clearance on 2024-09-26. The device is classified under product code MOU. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Intravascular radiation delivery system?

Intravascular radiation delivery system is a medical device that received FDA 510(k) clearance on 2024-09-26. The listed applicant is Best Vascular, Inc..

When did Intravascular radiation delivery system receive FDA 510(k) clearance?

The clearance date for Intravascular radiation delivery system can be found in the official FDA records.

Who is the listed applicant for Intravascular radiation delivery system?

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

What is the FDA product code for Intravascular radiation delivery system?

The FDA product code for Intravascular radiation delivery system is MOU.

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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