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FDA 510(k)

COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET

K-Number: K974897 · 1998-03-31

ApplicantCobe Cardiovascular, Inc.
Decision Date1998-03-31
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET 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 1998-03-31 under 510(k) number K974897. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET?

COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Cobe Cardiovascular, Inc.. The 510(k) number is K974897.

When did COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET receive FDA 510(k) clearance?

COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET received FDA 510(k) clearance on 1998-03-31, under 510(k) number K974897.

Who is the listed applicant for COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET?

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 BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET?

The FDA product code for COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET is CAC.

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Other records listing Cobe Cardiovascular, Inc. as applicant

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Related Devices (Code: CAC)

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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