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FDA 510(k)

EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE

K-Number: K891687 · 1989-05-31

ApplicantMedtronic Blood Systems, Inc.
Decision Date1989-05-31
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Blood Systems, Inc.. It received FDA 510(k) clearance on 1989-05-31 under 510(k) number K891687. 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 EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE?

EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE is a medical device that received FDA 510(k) clearance on 1989-05-31. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K891687.

When did EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE receive FDA 510(k) clearance?

EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE received FDA 510(k) clearance on 1989-05-31, under 510(k) number K891687.

Who is the listed applicant for EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE?

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

What is the FDA product code for EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE?

The FDA product code for EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE is DTZ.

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Related Devices (Code: 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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