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FDA 510(k)

CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE

K-Number: K951479 · 1995-06-15

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

Device Summary

CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE 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 K951479. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE?

CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE 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 K951479.

When did CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE receive FDA 510(k) clearance?

CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE received FDA 510(k) clearance on 1995-06-15, under 510(k) number K951479.

Who is the listed applicant for CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE?

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 CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE?

The FDA product code for CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE is FCM.

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Other records listing Trinity Laboratories, Inc. as applicant

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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: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, 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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