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FDA 510(k)

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS

K-Number: K931444 · 1994-05-27

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1994-05-27
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K931444. 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 PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS?

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K931444.

When did PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS receive FDA 510(k) clearance?

PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS received FDA 510(k) clearance on 1994-05-27, under 510(k) number K931444.

Who is the listed applicant for PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS?

The FDA product code for PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS 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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