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FDA 510(k)

J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO

K-Number: K853251 · 1985-10-16

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1985-10-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853251. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO?

J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K853251.

When did J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO receive FDA 510(k) clearance?

J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853251.

Who is the listed applicant for J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO?

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

What is the FDA product code for J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO?

The FDA product code for J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO is DTZ.

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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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