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FDA 510(k)

CRITIKON I.V. CATHETER PLACEMENT UNIT

K-Number: K813345 · 1982-01-12

ApplicantCritikon Company, LLC
Decision Date1982-01-12
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CRITIKON I.V. CATHETER PLACEMENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813345. 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 CRITIKON I.V. CATHETER PLACEMENT UNIT?

CRITIKON I.V. CATHETER PLACEMENT UNIT is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Critikon Company, LLC. The 510(k) number is K813345.

When did CRITIKON I.V. CATHETER PLACEMENT UNIT receive FDA 510(k) clearance?

CRITIKON I.V. CATHETER PLACEMENT UNIT received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813345.

Who is the listed applicant for CRITIKON I.V. CATHETER PLACEMENT UNIT?

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

What is the FDA product code for CRITIKON I.V. CATHETER PLACEMENT UNIT?

The FDA product code for CRITIKON I.V. CATHETER PLACEMENT UNIT is FOZ.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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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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