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FDA PMA

CATHETER, PERCUTANEOUS (VALVULOPLASTY)

PMA Number: P910054 · 2024-07-01

ApplicantToray Industries (America), Inc.
Decision Date2024-07-01
PMA NumberP910054
Product CodeMAD
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

CATHETER, PERCUTANEOUS (VALVULOPLASTY) is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 2024-07-01. The device is classified under product code MAD. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

CATHETER, PERCUTANEOUS (VALVULOPLASTY) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Toray Industries (America), Inc..

When did CATHETER, PERCUTANEOUS (VALVULOPLASTY) receive FDA 510(k) clearance?

The clearance date for CATHETER, PERCUTANEOUS (VALVULOPLASTY) can be found in the official FDA records.

Who is the listed applicant for CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

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

What is the FDA product code for CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

The FDA product code for CATHETER, PERCUTANEOUS (VALVULOPLASTY) is MAD.

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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