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FDA 510(k)

FLOW DIRECTED THERMAL-DILUTION CATHETER

K-Number: K821056 · 1982-05-18

ApplicantOximetrix, Inc.
Decision Date1982-05-18
Product Code
DecisionSubstantially Equivalent

Device Summary

FLOW DIRECTED THERMAL-DILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Oximetrix, Inc.. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K821056. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOW DIRECTED THERMAL-DILUTION CATHETER?

FLOW DIRECTED THERMAL-DILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Oximetrix, Inc.. The 510(k) number is K821056.

When did FLOW DIRECTED THERMAL-DILUTION CATHETER receive FDA 510(k) clearance?

FLOW DIRECTED THERMAL-DILUTION CATHETER received FDA 510(k) clearance on 1982-05-18, under 510(k) number K821056.

Who is the listed applicant for FLOW DIRECTED THERMAL-DILUTION CATHETER?

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

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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 PUMPK823007OPTICATH HEPARIN COATED, FLOW-DIRECTK821057FLOW DIRECTED THERMAL-DILUTION INFUSIONK820674OPTICATH

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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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