FDA PMA

Ventricular (assist) bypass

PMA Number: P870072 · 2016-06-14

ApplicantThoratec Laboratories Corp.

Decision Date2016-06-14

PMA NumberP870072

Product CodeDSQ

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCV

Device Summary

Ventricular (assist) bypass is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Laboratories Corp.. It received FDA 510(k) clearance on 2016-06-14. The device is classified under product code DSQ. It was reviewed by the CV advisory panel.

Frequently Asked Questions

What is the Ventricular (assist) bypass?

Ventricular (assist) bypass is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Thoratec Laboratories Corp..

When did Ventricular (assist) bypass receive FDA 510(k) clearance?

The clearance date for Ventricular (assist) bypass can be found in the official FDA records.

Who is the listed applicant for Ventricular (assist) bypass?

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

What is the FDA product code for Ventricular (assist) bypass?

The FDA product code for Ventricular (assist) bypass is DSQ.

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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.