Xtra

FDA 510(k) K131553 · Sorin Group Deutschland GmbH

Substantially Equivalent

510(k) numberK131553

Submission

Device name
Xtra
Applicant
Sorin Group Deutschland GmbH
Waltham, MA, US
Received
May 30, 2013
Decision date
March 21, 2014
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

Other 510(k)s with product code CAC

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K241236XTRA Collection sets; XTRA Sequestration set XCAC · Special Sorin Group Italia S.R.L.08/16/2024SE
K240426Aventus Clot Management SystemCAC · Traditional Inquis Medical05/14/2024SE
K240584XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special Sorin Group Italia S.R.L.04/29/2024SE
K231782FlowSaver Blood Return System (80-101)CAC · Special Inari Medical, Inc.07/14/2023SE
K221483FlowSaver Blood Return SystemCAC · Traditional Inari Medical, Inc.02/17/2023SE
K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional Haemonetics Corporation11/15/2022SE
K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional Atrium Medical Corporation09/03/2021SE
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

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Questions and answers

When was Xtra cleared by the FDA?

Xtra (K131553) received a 510(k) decision of Substantially Equivalent on March 21, 2014, 295 days after the submission was received.

What is the product code of K131553?

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