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FDA 510(k)

CATHETER CARE TRAY

K-Number: K901181 · 1990-07-20

ApplicantOrion Life Systems, Inc.
Decision Date1990-07-20
Product CodeFCM
Advisory CommitteeGU
DecisionUnknown

Device Summary

CATHETER CARE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Orion Life Systems, Inc.. It received FDA 510(k) clearance on 1990-07-20 under 510(k) number K901181. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CATHETER CARE TRAY?

CATHETER CARE TRAY is a medical device that received FDA 510(k) clearance on 1990-07-20. The listed applicant is Orion Life Systems, Inc.. The 510(k) number is K901181.

When did CATHETER CARE TRAY receive FDA 510(k) clearance?

CATHETER CARE TRAY received FDA 510(k) clearance on 1990-07-20, under 510(k) number K901181.

Who is the listed applicant for CATHETER CARE TRAY?

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

What is the FDA product code for CATHETER CARE TRAY?

The FDA product code for CATHETER CARE TRAY is FCM.

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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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