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FDA 510(k)

COBE OXYGENATOR PRODUCTS

K-Number: K974085 · 1998-01-27

ApplicantCobe Cardiovascular, Inc.
Decision Date1998-01-27
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COBE OXYGENATOR PRODUCTS is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Cardiovascular, Inc.. It received FDA 510(k) clearance on 1998-01-27 under 510(k) number K974085. 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 COBE OXYGENATOR PRODUCTS?

COBE OXYGENATOR PRODUCTS is a medical device that received FDA 510(k) clearance on 1998-01-27. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K974085.

When did COBE OXYGENATOR PRODUCTS receive FDA 510(k) clearance?

COBE OXYGENATOR PRODUCTS received FDA 510(k) clearance on 1998-01-27, under 510(k) number K974085.

Who is the listed applicant for COBE OXYGENATOR PRODUCTS?

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

What is the FDA product code for COBE OXYGENATOR PRODUCTS?

The FDA product code for COBE OXYGENATOR PRODUCTS is DTZ.

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Other records listing Cobe Cardiovascular, Inc. as applicant

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Related Devices (Code: DTZ)

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.

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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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