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FDA 510(k)

ORION RED URETHRAL CATHETER

K-Number: K944383 · 1994-12-06

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1994-12-06
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORION RED URETHRAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1994-12-06 under 510(k) number K944383. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION RED URETHRAL CATHETER?

ORION RED URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-12-06. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944383.

When did ORION RED URETHRAL CATHETER receive FDA 510(k) clearance?

ORION RED URETHRAL CATHETER received FDA 510(k) clearance on 1994-12-06, under 510(k) number K944383.

Who is the listed applicant for ORION RED URETHRAL CATHETER?

The FDA 510(k) record lists Regulatory & Marketing Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION RED URETHRAL CATHETER?

The FDA product code for ORION RED URETHRAL CATHETER is EZD.

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Other records listing Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

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Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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