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FDA 510(k)

BARD ISOFLOW BLOOD PUMP

K-Number: K971421 · 1998-05-14

ApplicantC.R. Bard, Inc.
Decision Date1998-05-14
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BARD ISOFLOW BLOOD PUMP 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 1998-05-14 under 510(k) number K971421. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD ISOFLOW BLOOD PUMP?

BARD ISOFLOW BLOOD PUMP is a medical device that received FDA 510(k) clearance on 1998-05-14. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K971421.

When did BARD ISOFLOW BLOOD PUMP receive FDA 510(k) clearance?

BARD ISOFLOW BLOOD PUMP received FDA 510(k) clearance on 1998-05-14, under 510(k) number K971421.

Who is the listed applicant for BARD ISOFLOW BLOOD PUMP?

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 BARD ISOFLOW BLOOD PUMP?

The FDA product code for BARD ISOFLOW BLOOD PUMP is DWA.

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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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