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FDA 510(k)

STANDARD FOLEY SYSTEM PAK

K-Number: K951443 · 1995-06-15

ApplicantTrinity Laboratories, Inc.
Decision Date1995-06-15
Product CodeFCN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STANDARD FOLEY SYSTEM PAK is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1995-06-15 under 510(k) number K951443. The device is classified under product code FCN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STANDARD FOLEY SYSTEM PAK?

STANDARD FOLEY SYSTEM PAK is a medical device that received FDA 510(k) clearance on 1995-06-15. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K951443.

When did STANDARD FOLEY SYSTEM PAK receive FDA 510(k) clearance?

STANDARD FOLEY SYSTEM PAK received FDA 510(k) clearance on 1995-06-15, under 510(k) number K951443.

Who is the listed applicant for STANDARD FOLEY SYSTEM PAK?

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

What is the FDA product code for STANDARD FOLEY SYSTEM PAK?

The FDA product code for STANDARD FOLEY SYSTEM PAK is FCN.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK974286CIRCUMCISION TRAY, CAT. NO. 70340K972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE

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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.

K945258CATCO URINARY COLLECTION KITCatco Medical, 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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