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FDA 510(k)

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

K-Number: K972100 · 1997-07-31

ApplicantAdvanced Care Medical Products
Decision Date1997-07-31
Product CodeEXJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Care Medical Products. It received FDA 510(k) clearance on 1997-07-31 under 510(k) number K972100. The device is classified under product code EXJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)?

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) is a medical device that received FDA 510(k) clearance on 1997-07-31. The listed applicant is Advanced Care Medical Products. The 510(k) number is K972100.

When did VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) receive FDA 510(k) clearance?

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) received FDA 510(k) clearance on 1997-07-31, under 510(k) number K972100.

Who is the listed applicant for VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)?

The FDA 510(k) record lists Advanced Care Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)?

The FDA product code for VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) is EXJ.

Related Clinical Trials

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.

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Related Devices (Code: EXJ)

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.

K970465BOUSER'S URINALGeneral PolymersK970966COMFORT CATH CHOICE MALE EXTERNAL CATHETERSierra Laboratories, Inc.K963265PROSYS SAMEC LAConvatec, A Division of E.R. Squibb & SonsK962900SELF RETAINING MALE EXTERNAL URINARY CATHETERHollister, Inc.K962384COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETERSierra Laboratories, Inc.K962413COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETERSierra Laboratories, Inc.

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.

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