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FDA 510(k)

MAT MEMBRANE AUTOTRANSFUSION SYSTEM

K-Number: K915130 · 1993-02-22

ApplicantEstracorporeal, Inc.
Decision Date1993-02-22
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAT MEMBRANE AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Estracorporeal, Inc.. It received FDA 510(k) clearance on 1993-02-22 under 510(k) number K915130. 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 MAT MEMBRANE AUTOTRANSFUSION SYSTEM?

MAT MEMBRANE AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 1993-02-22. The listed applicant is Estracorporeal, Inc.. The 510(k) number is K915130.

When did MAT MEMBRANE AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

MAT MEMBRANE AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 1993-02-22, under 510(k) number K915130.

Who is the listed applicant for MAT MEMBRANE AUTOTRANSFUSION SYSTEM?

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

What is the FDA product code for MAT MEMBRANE AUTOTRANSFUSION SYSTEM?

The FDA product code for MAT MEMBRANE AUTOTRANSFUSION SYSTEM 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 Estracorporeal, 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.

K790382COIL DIALYSIS, MODELS DM-360 AND DM-360-

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

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