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FDA 510(k)

INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER

K-Number: K864949 · 1987-02-25

ApplicantQuinton, Inc.
Decision Date1987-02-25
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-02-25 under 510(k) number K864949. 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 INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER?

INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER is a medical device that received FDA 510(k) clearance on 1987-02-25. The listed applicant is Quinton, Inc.. The 510(k) number is K864949.

When did INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER receive FDA 510(k) clearance?

INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER received FDA 510(k) clearance on 1987-02-25, under 510(k) number K864949.

Who is the listed applicant for INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER?

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

What is the FDA product code for INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER?

The FDA product code for INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER is FOZ.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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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