FDA 510(k)

FLEX-IV

K-Number: K911251 · 1991-10-28

ApplicantMedway

Decision Date1991-10-28

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FLEX-IV is the device name listed in this FDA 510(k) record. The listed applicant is Medway. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K911251. 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 FLEX-IV?

FLEX-IV is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Medway. The 510(k) number is K911251.

When did FLEX-IV receive FDA 510(k) clearance?

FLEX-IV received FDA 510(k) clearance on 1991-10-28, under 510(k) number K911251.

Who is the listed applicant for FLEX-IV?

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

What is the FDA product code for FLEX-IV?

The FDA product code for FLEX-IV is FOZ.

Other records listing Medway 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.

K934344HOME AMB-ALERT K931952MEDWAY OXYGEN MASK K911079AMB-ALERT K910880COMFOR-BOARD

Related Devices (Code: FOZ)

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum Vascular K261041ClearSafe Closed SystemMedSource Labs, LLC K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLC K253235Introcan 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.