Orthopedic Perioperative Autotransfusion (Orthopat) System

FDA 510(k) K982660 · Transfusion Technologies Corp.

Substantially Equivalent

510(k) numberK982660

Submission

Device name
Orthopedic Perioperative Autotransfusion (Orthopat) System
Applicant
Transfusion Technologies Corp.
Natick, MA, US
Received
July 30, 1998
Decision date
March 30, 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
CAC – Apparatus, Autotransfusion
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5830
Specialty
Anesthesiology
Life-sustaining
Yes

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K210862Hemafuse SystemCAC · Traditional Sisu Global Health07/29/2021SE
K210176FlowSaver Blood FilterCAC · Traditional Inari Medical07/22/2021SE
K210089CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special Fresenius Kabi AG02/11/2021SE

More from Fresenius Kabi AG

510(k)DeviceDecision
K992723Orthopedic Perioperative Autotransfusion (Orthopat) SystemCAC · Traditional 10/18/1999SE
K962475Orthopedic Perioperative Autotransfusion (Orthopat) SystemCAC · Traditional 02/20/1997SE

Questions and answers

When was Orthopedic Perioperative Autotransfusion (Orthopat) System cleared by the FDA?

Orthopedic Perioperative Autotransfusion (Orthopat) System (K982660) received a 510(k) decision of Substantially Equivalent on March 30, 1999, 243 days after the submission was received.

What is the product code of K982660?

The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.