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FDA 510(k)

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.

K-Number: K891230 · 1989-05-19

ApplicantMedtronic Blood Systems, Inc.
Decision Date1989-05-19
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. 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 1989-05-19 under 510(k) number K891230. 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 MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.?

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. is a medical device that received FDA 510(k) clearance on 1989-05-19. The listed applicant is Medtronic Blood Systems, Inc.. The 510(k) number is K891230.

When did MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. receive FDA 510(k) clearance?

MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. received FDA 510(k) clearance on 1989-05-19, under 510(k) number K891230.

Who is the listed applicant for MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.?

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 MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.?

The FDA product code for MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. 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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