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FDA 510(k)

BARD MALE EXTERNAL CATHETER

K-Number: K802433 · 1980-10-31

ApplicantC.R. Bard, Inc.
Decision Date1980-10-31
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BARD MALE EXTERNAL CATHETER 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 1980-10-31 under 510(k) number K802433. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARD MALE EXTERNAL CATHETER?

BARD MALE EXTERNAL CATHETER is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K802433.

When did BARD MALE EXTERNAL CATHETER receive FDA 510(k) clearance?

BARD MALE EXTERNAL CATHETER received FDA 510(k) clearance on 1980-10-31, under 510(k) number K802433.

Who is the listed applicant for BARD MALE EXTERNAL CATHETER?

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 MALE EXTERNAL CATHETER?

The FDA product code for BARD MALE EXTERNAL CATHETER is KNX.

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Other records listing C.R. Bard, Inc. as applicant

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Related Devices (Code: KNX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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