Fresenius ATR40 and ATR120 Autotransfusion Reservoirs

FDA 510(k) K984586 · Fresenius Hemotechnology, Inc.

Substantially Equivalent

510(k) numberK984586

Submission

Device name
Fresenius ATR40 and ATR120 Autotransfusion Reservoirs
Applicant
Fresenius Hemotechnology, Inc.
Concord, CA, US
Received
December 24, 1998
Decision date
June 29, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTN – Reservoir, Blood, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4400
Specialty
Cardiovascular

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More from Medtronic, Inc.

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K012178Fresenius C.A.T.S; Ati Autotransfusion Set; PSQ Plasma Sequestration Set; Psq-Dd Plasma…CAC · Special 07/23/2001SE
K984233C.A.T.S Autotransfusion Accessories, Models Ats Suction Line, Aty Y-Adapter, and Ato…CAC · Traditional 02/01/1999SE

Questions and answers

When was Fresenius ATR40 and ATR120 Autotransfusion Reservoirs cleared by the FDA?

Fresenius ATR40 and ATR120 Autotransfusion Reservoirs (K984586) received a 510(k) decision of Substantially Equivalent on June 29, 1999, 187 days after the submission was received.

What is the product code of K984586?

The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.