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FDA 510(k)

ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

K-Number: K944379 · 1995-02-15

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1995-02-15
Product CodeFGM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG 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 1995-02-15 under 510(k) number K944379. The device is classified under product code FGM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG?

ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG is a medical device that received FDA 510(k) clearance on 1995-02-15. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K944379.

When did ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG receive FDA 510(k) clearance?

ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG received FDA 510(k) clearance on 1995-02-15, under 510(k) number K944379.

Who is the listed applicant for ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG?

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'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG?

The FDA product code for ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG is FGM.

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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 KITK944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG

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Related Devices (Code: FGM)

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.

K041732CAVERMAP SURGICAL AIDBlue Torch Medical TechnologiesK031527MODIFICATION TO CAVERMAP SURGICAL AIDBlue Torch Medical TechnologiesK010098MODIFICATION TO CAVERMAP SURGICAL AIDUromed Corp.K993436CAVERMAP SURGICAL AIDUromed Corp.K944384ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAGRegulatory & Marketing Services, Inc.K944378ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAGRegulatory & Marketing Services, 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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