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FDA 510(k)

FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS

K-Number: K984586 · 1999-06-29

ApplicantFresenius Hemotechnology, Inc.
Decision Date1999-06-29
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Hemotechnology, Inc.. It received FDA 510(k) clearance on 1999-06-29 under 510(k) number K984586. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS?

FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS is a medical device that received FDA 510(k) clearance on 1999-06-29. The listed applicant is Fresenius Hemotechnology, Inc.. The 510(k) number is K984586.

When did FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS receive FDA 510(k) clearance?

FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS received FDA 510(k) clearance on 1999-06-29, under 510(k) number K984586.

Who is the listed applicant for FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS?

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

What is the FDA product code for FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS?

The FDA product code for FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS is DTN.

Related Clinical Trials

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Other records listing Fresenius Hemotechnology, Inc. as applicant

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.

K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAWK984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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