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FDA 510(k)

CUFF-CATH

K-Number: K935090 · 1994-10-14

ApplicantOhmeda Medical
Decision Date1994-10-14
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUFF-CATH is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1994-10-14 under 510(k) number K935090. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUFF-CATH?

CUFF-CATH is a medical device that received FDA 510(k) clearance on 1994-10-14. The listed applicant is Ohmeda Medical. The 510(k) number is K935090.

When did CUFF-CATH receive FDA 510(k) clearance?

CUFF-CATH received FDA 510(k) clearance on 1994-10-14, under 510(k) number K935090.

Who is the listed applicant for CUFF-CATH?

The FDA 510(k) record lists Ohmeda Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUFF-CATH?

The FDA product code for CUFF-CATH is FOZ.

Other records listing Ohmeda Medical 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.

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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