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FDA 510(k)

START IT WITH & WITHOUT I.V. CATH. UNIT

K-Number: K801537 · 1980-09-19

ApplicantPioneer Viggo, Inc.
Decision Date1980-09-19
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

START IT WITH & WITHOUT I.V. CATH. UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Viggo, Inc.. It received FDA 510(k) clearance on 1980-09-19 under 510(k) number K801537. 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 START IT WITH & WITHOUT I.V. CATH. UNIT?

START IT WITH & WITHOUT I.V. CATH. UNIT is a medical device that received FDA 510(k) clearance on 1980-09-19. The listed applicant is Pioneer Viggo, Inc.. The 510(k) number is K801537.

When did START IT WITH & WITHOUT I.V. CATH. UNIT receive FDA 510(k) clearance?

START IT WITH & WITHOUT I.V. CATH. UNIT received FDA 510(k) clearance on 1980-09-19, under 510(k) number K801537.

Who is the listed applicant for START IT WITH & WITHOUT I.V. CATH. UNIT?

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

What is the FDA product code for START IT WITH & WITHOUT I.V. CATH. UNIT?

The FDA product code for START IT WITH & WITHOUT I.V. CATH. UNIT is FOZ.

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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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Other records listing Pioneer Viggo, 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.

K823120EXACTA & CONNECTA STOPCOCKS W/EXTENSIONK813454I.V. FILTER-PREVENTK812159INTRAVASCULAR CATHETERK811171VASCULON II I.V. CATHETERK791809BLOOD TRANSFUSION MICROFILTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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