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FDA 510(k)

OPTICATH HEPARIN COATED, FLOW-DIRECT

K-Number: K823007 · 1982-11-01

ApplicantOximetrix, Inc.
Decision Date1982-11-01
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTICATH HEPARIN COATED, FLOW-DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K823007. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICATH HEPARIN COATED, FLOW-DIRECT?

OPTICATH HEPARIN COATED, FLOW-DIRECT is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Oximetrix, Inc.. The 510(k) number is K823007.

When did OPTICATH HEPARIN COATED, FLOW-DIRECT receive FDA 510(k) clearance?

OPTICATH HEPARIN COATED, FLOW-DIRECT received FDA 510(k) clearance on 1982-11-01, under 510(k) number K823007.

Who is the listed applicant for OPTICATH HEPARIN COATED, FLOW-DIRECT?

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

What is the FDA product code for OPTICATH HEPARIN COATED, FLOW-DIRECT?

The FDA product code for OPTICATH HEPARIN COATED, FLOW-DIRECT is DYG.

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Other records listing Oximetrix, 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.

K853018MODEL 3000 OPTICATH COMPUTERK842622HEMO STATIC/ESU SCALPEL SYSTEMK833966PUMP INFUSION WEARABLE INFUSION PUMPK821057FLOW DIRECTED THERMAL-DILUTION INFUSIONK821056FLOW DIRECTED THERMAL-DILUTION CATHETERK820674OPTICATH

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Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, LLC

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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