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FDA 510(k)

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW

K-Number: K012178 · 2001-07-23

ApplicantFresenius Hemotechnology, Inc.
Decision Date2001-07-23
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW 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 2001-07-23 under 510(k) number K012178. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW?

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW is a medical device that received FDA 510(k) clearance on 2001-07-23. The listed applicant is Fresenius Hemotechnology, Inc.. The 510(k) number is K012178.

When did FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW receive FDA 510(k) clearance?

FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW received FDA 510(k) clearance on 2001-07-23, under 510(k) number K012178.

Who is the listed applicant for FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW?

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 C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW?

The FDA product code for FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW is CAC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSK984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE

Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

Official Source

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