FDA 510(k)

BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS

K-Number: K973962 · 1998-02-19

Decision Date1998-02-19

Product CodeDSP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS 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 1998-02-19 under 510(k) number K973962. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS?

BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS is a medical device that received FDA 510(k) clearance on 1998-02-19. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K973962.

When did BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS receive FDA 510(k) clearance?

BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS received FDA 510(k) clearance on 1998-02-19, under 510(k) number K973962.

Who is the listed applicant for BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS?

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 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS?

The FDA product code for BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS is DSP.

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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.