FDA 510(k)

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU

K-Number: K851323 · 1985-08-12

Decision Date1985-08-12

Product CodeDWF

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K851323. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU?

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K851323.

When did AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU receive FDA 510(k) clearance?

AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU received FDA 510(k) clearance on 1985-08-12, under 510(k) number K851323.

Who is the listed applicant for AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU?

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

What is the FDA product code for AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU?

The FDA product code for AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU is DWF.

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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.