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FDA 510(k)

TRAY, CATHETERIZATION W/ CATHETER

K-Number: K760128 · 1976-10-07

ApplicantConcord Laboratories, Inc.
Decision Date1976-10-07
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRAY, CATHETERIZATION W/ CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1976-10-07 under 510(k) number K760128. 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 TRAY, CATHETERIZATION W/ CATHETER?

TRAY, CATHETERIZATION W/ CATHETER is a medical device that received FDA 510(k) clearance on 1976-10-07. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K760128.

When did TRAY, CATHETERIZATION W/ CATHETER receive FDA 510(k) clearance?

TRAY, CATHETERIZATION W/ CATHETER received FDA 510(k) clearance on 1976-10-07, under 510(k) number K760128.

Who is the listed applicant for TRAY, CATHETERIZATION W/ CATHETER?

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

What is the FDA product code for TRAY, CATHETERIZATION W/ CATHETER?

The FDA product code for TRAY, CATHETERIZATION W/ CATHETER is FCM.

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Other records listing Concord Laboratories, Inc. as applicant

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Related Devices (Code: FCM)

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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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