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FDA 510(k)

CATCO URINARY COLLECTION KIT

K-Number: K945258 · 1995-02-16

ApplicantCatco Medical, Inc.
Decision Date1995-02-16
Product CodeFCN
Advisory CommitteeGU
DecisionUnknown

Device Summary

CATCO URINARY COLLECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Catco Medical, Inc.. It received FDA 510(k) clearance on 1995-02-16 under 510(k) number K945258. The device is classified under product code FCN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CATCO URINARY COLLECTION KIT?

CATCO URINARY COLLECTION KIT is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is Catco Medical, Inc.. The 510(k) number is K945258.

When did CATCO URINARY COLLECTION KIT receive FDA 510(k) clearance?

CATCO URINARY COLLECTION KIT received FDA 510(k) clearance on 1995-02-16, under 510(k) number K945258.

Who is the listed applicant for CATCO URINARY COLLECTION KIT?

The FDA 510(k) record lists Catco Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATCO URINARY COLLECTION KIT?

The FDA product code for CATCO URINARY COLLECTION KIT is FCN.

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Other records listing Catco Medical, Inc. as applicant

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.

K945728CATCO THORACIC CATHETERK944368CATCO SILICONE UMBILICAL VESSEL CATHETERK944410CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETERK944336CATCO UMBILICAL VESSEL CATHETERK944367CATCO POLYURETHANE UMBILICAL VESSEL CATHETERK944685CATO FIRST PICC-DUAL LUMEN

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Related Devices (Code: FCN)

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.

K951443STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.K915166MICROCYCLERMedical Inventors Corp., Inc.K922346FEMALE URINE SAMPLING DEVICEMentor Corp.K890096BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.K883886DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.K883610LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, 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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