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FDA 510(k)

LUMED EXPANDO-CATH, ACTIV

K-Number: K884806 · 1989-02-08

ApplicantLuther Medical Products, Inc.
Decision Date1989-02-08
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUMED EXPANDO-CATH, ACTIV is the device name listed in this FDA 510(k) record. The listed applicant is Luther Medical Products, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K884806. 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 LUMED EXPANDO-CATH, ACTIV?

LUMED EXPANDO-CATH, ACTIV is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Luther Medical Products, Inc.. The 510(k) number is K884806.

When did LUMED EXPANDO-CATH, ACTIV receive FDA 510(k) clearance?

LUMED EXPANDO-CATH, ACTIV received FDA 510(k) clearance on 1989-02-08, under 510(k) number K884806.

Who is the listed applicant for LUMED EXPANDO-CATH, ACTIV?

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

What is the FDA product code for LUMED EXPANDO-CATH, ACTIV?

The FDA product code for LUMED EXPANDO-CATH, ACTIV is FOZ.

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Other records listing Luther Medical Products, 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.

K982797BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICBK980090ONECATH, L-CATH CATHETER SYSTEM, MODEL OC-(16-22 GA., 5CM-60CM)K974543L-CATH MODIFIED SELDINGER TECHNIQUE INSERTION/CATHETER EXCHANGE KIT PE-MST24-24 GA. KIT, L-CATH MODIFIED SELDINGERK940198L-CATH CONNECTOR ASSEMBLYK942103L-CATH CATHETER SYSTEM - PORT L-CATHK930473ONECATH L-CATH CATHETER SYSTEM

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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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