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FDA 510(k)

BARD BALLOON INFLATION SYSTEM

K-Number: K991375 · 1999-09-10

ApplicantC.R. Bard, Inc.
Decision Date1999-09-10
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD BALLOON INFLATION SYSTEM 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 1999-09-10 under 510(k) number K991375. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD BALLOON INFLATION SYSTEM?

BARD BALLOON INFLATION SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-10. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K991375.

When did BARD BALLOON INFLATION SYSTEM receive FDA 510(k) clearance?

BARD BALLOON INFLATION SYSTEM received FDA 510(k) clearance on 1999-09-10, under 510(k) number K991375.

Who is the listed applicant for BARD BALLOON INFLATION SYSTEM?

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 BALLOON INFLATION SYSTEM?

The FDA product code for BARD BALLOON INFLATION SYSTEM is KNT.

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Related Devices (Code: KNT)

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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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